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| ID | Type | Description | Link |
|---|---|---|---|
| 206988031815 | Other Identifier | Loyola University Chicago |
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the study was halted prematurely due to slow recruitment and expiration of funding
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population. There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes. Strategies to prevent cognitive decline in persons with diabetes has not been well studied. A recent study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and Alzheimer's was doubled. Vitamin D receptors are located in the brain and deficiency of vitamin D has been reported to negatively affect the development of brain. Therefore, providing vitamin D supplementation to improve cognitive function is worthy of study. The investigators propose a small, randomized controlled trial to determine the effects of vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months. The study aims are to determine (1) the effect of vitamin D3 supplementation on cognitive function and (2) the effect of vitamin D3 supplementation on diabetes self-management. A sample of persons with type 2 diabetes (n=62), who have a subjective complaint of a cognitive dysfunction or scoring at least one standard deviation below normal on a cognitive functioning screening test, have vitamin D levels less 30 ng/ml, are not depressed (as this impacts cognitive function), and do not have severe diabetes complication will be recruited. Participants will be phone screened and complete two baseline visits prior to randomization. They will then have phone call and follow-up visits to assess (1) cognitive function using standardized tests to assess for executive function (2) serum measurements (HBA1c, fasting glucose, vitamin D levels, and cardiometabolic profile) and (3) surveys to assess cognitive function as well as self-management behaviors.
Study Aims Diabetes increases the risk of cognitive dysfunction. The incidence of dementia is 1.5 to 2.5 times higher in persons with diabetes than the general population (1). There is evidence that cognitive decline significantly impacts the ability to self-manage diabetes (2). Strategies to prevent cognitive decline in persons with diabetes has not been well studied. A recent study reported that in persons who had vitamin D deficiency, the risk for all-cause dementia and Alzheimer's was doubled (3). Vitamin D receptors are located in the brain, and deficiency of vitamin D has been reported to negatively affect the development of brain and impact both growth factor signaling and neural activity (4, 5). Therefore, providing vitamin D supplementation to improve cognitive function in persons with diabetes who are at great risk for this comorbid condition is important. The investigators propose a small, randomized controlled trial to determine the effects of vitamin D3 supplementation in persons with type 2 diabetes who have symptoms of cognitive impairment. Persons will be randomized to receive either weekly vitamin D3 supplementation (50,000 IUs) or a matching comparator (5000 IUs) for a period of three months.
Primary Aim: To determine the effect of vitamin D3 supplementation on cognitive function for persons with type 2 diabetes.
Primary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will have improved cognitive function compared to those receiving the comparator (5000 IUs) at three months.
Secondary Aim: To determine the effect of vitamin D3 supplementation on diabetes self-management.
Secondary Hypothesis: Persons receiving weekly vitamin D3 supplementation (50,000 IUs) will have improved self-management compared to those receiving the comparator (5000 IUs) at three months.
The importance of this study is several fold. Vitamin D supplementation is a low cost intervention (6), it has minimal side effects (7), and it could have high impact for persons with type 2 diabetes who suffer from cognitive impairment which can significantly affect their diabetes self-management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental | 50,000 IU cholecalciferol once weekly for three months |
|
| Low Dose | Active Comparator | 5,000 IU cholecalciferol once weekly for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Participants will take randomly assigned high dose cholecalciferol once weekly for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Letter-Number Sequencing | The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance. | 13 weeks |
| Controlled Oral Word Association Test | The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | 13 Weeks |
| Stroop Interference Test | The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | 13 Weeks |
| Symbol-Digit Modality Test | The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Verbal Learning Total Recall Test | The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary A Byrn, Ph.D., R.N. | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25031883 | Background | Lee JH, Choi Y, Jun C, Hong YS, Cho HB, Kim JE, Lyoo IK. Neurocognitive changes and their neural correlates in patients with type 2 diabetes mellitus. Endocrinol Metab (Seoul). 2014 Jun;29(2):112-21. doi: 10.3803/EnM.2014.29.2.112. | |
| 24898849 | Background | Smith MA, Else JE, Paul L, Foster JK, Walker M, Wesnes KA, Riby LM. Functional Living in Older Adults With Type 2 Diabetes: Executive Functioning, Dual Task Performance, and the Impact on Postural Stability and Motor Control. J Aging Health. 2014 Aug;26(5):841-859. doi: 10.1177/0898264314534896. Epub 2014 Jun 4. |
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There is no plan to share individual participant data with other researchers
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Fifty-six participants consented to participate in the study. Among these individuals, 26 (46.43%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they did not meet study inclusion criteria.
Recruitment for this study took place at Loyola University Medical Center (Maywood, IL) between September 2015 and June 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | 5,000 IU cholecalciferol once weekly for three months |
| FG001 | High Dose | 50,000 IU cholecalciferol once weekly for three months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline analysis population comprises all individuals who consented to participate and took at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | 5,000 IU cholecalciferol once weekly for three months |
| BG001 | High Dose | 50,000 IU cholecalciferol once weekly for three months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Letter-Number Sequencing | The the Letter-Number Sequencing Test (from the Wechsler Adult Intelligence Scale-III assessment) is an assessment of working memory. Scores on the assessment are standardized as scaled scores with a mean of 10 and standard deviation of 3 (μ = 10, SD = 3) using age adjusted normative data provided by Pearson assessments (https://www.pearsonassessments.com/). A scaled score indicates the number of standard deviations away from the mean. A scaled score of 10 is equal to the mean. Scaled scores below 10 indicate performance is lower than average, and scaled scores higher than 10 indicate performance is higher than average. Higher scaled scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 weeks |
|
Adverse event data were collected for 20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | 5,000 IU cholecalciferol once weekly for three months | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold virus | Infections and infestations | Non-systematic Assessment |
The trial experienced early termination leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Byrn, R.N., Ph.D. | Loyola University Chicago | (773) 508-8973 | mbyrn@luc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2017 | Nov 2, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2018 | Nov 2, 2019 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
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| Cholecalciferol | Drug | Participants will take randomly assigned active comparator cholecalciferol once weekly for three months |
|
|
| 13 Weeks |
| Trail Making Test Part B | The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | 13 Weeks |
| 13 weeks |
| Semantic Fluency Test | The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | 13 Weeks |
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| 24750335 | Background | Retracted: Executive dysfunction in elderly diabetic patients. Geriatr Gerontol Int. 2015 Aug;15(8):1106. doi: 10.1111/ggi.12288. Epub 2014 Apr 21. No abstract available. |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of education | Median | Inter-Quartile Range | years |
|
| Total vitamin D level | Median | Inter-Quartile Range | Nanograms per milliliter (ng/mL) |
|
| Serum vitamin D3 level | Median | Inter-Quartile Range | Nanograms per milliliter (ng/mL) |
|
| Body mass index | Mean | Standard Deviation | kilograms per meter squared (kg/m^2) |
|
| Martial status | Count of Participants | Participants |
|
| Season of first dose of the study drug | Count of Participants | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | Millimeters of mercury (mmHg) |
|
| Diastolic blood pressure | Mean | Standard Deviation | Millimeters of mercury (mmHg) |
|
| Heart rate | Mean | Standard Deviation | Beats per minute (BPM) |
|
| HbA1c | Median | Inter-Quartile Range | mmol/mol |
|
| Glucose | Median | Inter-Quartile Range | Millimoles per liter (mmol/L) |
|
| Calcium | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) |
|
| Creatinine | Median | Inter-Quartile Range | milligrams per deciliter (mg/dL) |
|
| Activity level | Baseline physical activity was assessed using the Godin Leisure-Time Exercise Questionnaire. The measure of physical activity ranges from 0 to infinity points. Scores less than 14 points on this assessment indicate insufficient physical activity while scores of 24 or higher indicate sufficient physical activity; other scores are categorized as being moderately active. | Count of Participants | Participants |
|
| WRAT-IV Reading Score | The Wide Range Achievement Test (WRAT-IV) reading subtest score is a 55-item assessment of letter and word decoding through letter identification and word recognition. Scores are standardized as z-scores using age-adjusted norms provided by Pearson Assessments (https://www.pearsonassessments.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | Median | Inter-Quartile Range | units on a scale |
|
| Patient Health Questionnaire-9 | The Patient Health Questionnaire-9 is an assessment of depression. Scores range from 1 to 27 points with higher scores indicating worse mood. | Median | Inter-Quartile Range | units on a scale |
|
| CES-D Score | The Center for Epidemiologic Studies Depression (CES-D) assessment measures mood. Scores range from 0 to 60 points with higher scores indicating worse symptoms | Mean | Standard Deviation | units on a scale |
|
5,000 IU cholecalciferol once weekly for three months
| OG001 | High Dose | 50,000 IU cholecalciferol once weekly for three months |
|
|
| Primary | Controlled Oral Word Association Test | The Controlled Oral Word Association Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
|
|
|
| Primary | Stroop Interference Test | The Stroop Interference Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
|
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| Primary | Symbol-Digit Modality Test | The Symbol-Digit Modality Test is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
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| Primary | Trail Making Test Part B | The Trail Making Test Part B is a measure of executive functioning. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by WPS Publishers (https://www.wpspublish.com/). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
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| Secondary | Hopkins Verbal Learning Total Recall Test | The Hopkins Verbal Learning Total Recall Test is an assessment of memory. Scores are standardized as T-scores (μ = 50, SD = 10) using age adjusted normative data provided by PAR Incorporated (https://www.parinc.com/). A T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. T-scores below 50 indicate performance is lower than average, and T-scores above 50 indicate performance is higher than average. Higher T-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 weeks |
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| Secondary | Semantic Fluency Test | The Semantic Fluency Test is a measure of verbal fluency. Scores are standardized as z-scores (μ = 0, SD = 1) using age adjusted normative data provided by Tombaugh and Kozak (1996). A z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean. Negative z-scores indicate performance is lower than average, and positive z-scores indicate performance is higher than average. Positive z-scores indicate better performance. | The analysis population comprises all individuals who signed an informed consent document and took at least one dose of the study drug. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
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| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | High Dose | 50,000 IU cholecalciferol once weekly for three months | 0 | 15 | 1 | 15 | 9 | 15 |
| Short menstrual period | Reproductive system and breast disorders | Non-systematic Assessment |
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| Menstrual cramps | Reproductive system and breast disorders | Non-systematic Assessment |
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| Arm pain | General disorders | Non-systematic Assessment |
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| Toothache | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Cataracts | Eye disorders | Non-systematic Assessment |
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| Hypercalcemia | Endocrine disorders | Non-systematic Assessment |
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| Hemorrhoids | Renal and urinary disorders | Non-systematic Assessment |
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| Poor appetite | General disorders | Non-systematic Assessment |
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| Dark stools | Gastrointestinal disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sinus infection | Infections and infestations | Non-systematic Assessment |
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| Strep throat | Infections and infestations | Non-systematic Assessment |
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| Sore throat | General disorders | Non-systematic Assessment |
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| Fall | Nervous system disorders | Non-systematic Assessment |
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| Tiredness | General disorders | Non-systematic Assessment |
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| Muscle aches | General disorders | Non-systematic Assessment |
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| Goiter | Endocrine disorders | Non-systematic Assessment |
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| Arhritis | General disorders | Non-systematic Assessment |
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| Foot pain | General disorders | Non-systematic Assessment |
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| Restlessness | General disorders | Non-systematic Assessment |
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| Shoulder pain | General disorders | Non-systematic Assessment |
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| Knee cyst | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Leg cramps | General disorders | Non-systematic Assessment |
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| Motor vehicle accident | Social circumstances | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
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Not provided
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |