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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR013906-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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This is a randomized clinical trial (RCT) to determine the effectiveness of vitamin D3 supplementation on depressive symptoms, self-management, and blood pressure in approximately 180 adult women with type 2 diabetes who have significant depressive symptoms. Consenting adult women who are eligible to participate will be randomly assigned to either a weekly dose of 50,000 international units of vitamin D3 supplementation or a matching weekly active comparator of 5,000 international units of vitamin D3 for six months. Participants will complete approximately four in-person study visits and several telephone visits throughout the six month trial period, where the researchers will assess depressive symptoms, diabetes self-management, and systolic blood pressure.
The primary aim of this study is to determine the effect of vitamin D supplementation on depressive symptoms, self-management, and systolic blood pressure compared to placebo. The hypothesis is that women receiving vitamin D supplementation will report fewer depressive symptoms, increased diabetes self- management mediated by depression improvement, and will have a lower systolic blood pressure compared to those taking placebo at three and six months follow-up.
The secondary aim is to explore the mechanistic effect of vitamin D supplementation on inflammatory biomarkers and their association with depression. Here, the hypothesis is that women receiving vitamin D supplementation will have a decrease in inflammatory biomarkers which will be associated with fewer depressive symptoms compared to those taking placebo at three and six months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 | Experimental | 50,000 international units (IUs) weekly Vitamin D3 |
|
| Vitamin D3 comparator | Active Comparator | 5,000 international units (IUs) of a weekly Vitamin D3 comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 50,000 international units (IUs) weekly Vitamin D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Penckofer, Ph.D., R.N. | Loyola University Chicago Health Sciences Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
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Two-hundred sixty-five participants consented to participate in the study. Among these individuals, 136 (51.3%) were not randomized for failing to meet study inclusion criteria (134/136 or 98.5%) or because they withdrew consent prior to randomization (2/136 or 1.5%).
Subjects were recruited from November 2013 through November 2017 (48 months)
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | 5,000 international units (IUs) of a weekly Vitamin D3 comparator |
| FG001 | High Dose | 50,000 international units (IUs) weekly Vitamin D3 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population comprises all patients randomized to high dose or lose dose therapy
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | 5,000 international units (IUs) of a weekly Vitamin D3 comparator |
| BG001 | High Dose | 50,000 international units (IUs) weekly Vitamin D3 |
| 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 | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | The Center for Epidemiologic Studies Depression (CES-D) is a self-report questionnaire assessing frequency and severity of depression symptoms. Raw scores range from 0 to 60, where higher scores indicate worse mood. For each participant, her baseline CES-D score is subtracted from her month 6 CES-D score to create a CES-D change score. | The analysis population includes all women randomized to low dose or high dose therapy and completed the month 6 CES-D assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
Adverse event data were collected for seven months
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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 international units (IUs) of a weekly Vitamin D3 comparator | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right sided weakness | Nervous system disorders | Non-systematic Assessment | Right sided weakness resulting in an inpatient hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
There are no limitations or caveats to report
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Penckofer, Ph.D., F.A.A.N. | Loyola University Chicago | 773-508-8949 | spencko@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 | Apr 26, 2019 | Sep 30, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2017 | Sep 30, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003863 | Depression |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Participants are randomized to either 50,000 international units of weekly vitamin D3 or to 5,000 international units of weekly vitamin D3 using a 1:1 allocation
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| Vitamin D3 comparator | Drug | 5,000 international units (IUs) of a weekly Vitamin D3 comparator |
|
|
| Baseline and 6 months |
| Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score. | Baseline and 6 months |
| Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score. | Baseline and 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Use of anti-depressants | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Annual Household Income | Count of Participants | Participants |
|
| CES-D | The Center for Epidemiologic Studies Depression (CES-D) score is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood. | Mean | Standard Deviation | units on a scale |
|
| PHQ-9 | The Patient Health Questionnaire (PHQ) is a self-administered depression screening inventory. Scores range from 0 to 27 with higher scores indicating worse mood | Mean | Standard Deviation | units on a scale |
|
| Vitamin D3 Level | Mean | Standard Deviation | ng/mL |
|
| Parathyroid Hormone | Median | Inter-Quartile Range | ng/L |
|
| Calcium | Median | Inter-Quartile Range | mg/dL |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| HBA1C | Mean | Standard Deviation | percentage of hemoglobin |
|
| Fasting glucose | Mean | Standard Deviation | mg/dL |
|
| High Dose |
50,000 international units (IUs) weekly Vitamin D3 |
|
|
|
| Secondary | Change in Problem Areas in Diabetes (PAIDS) Score From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | The Problem Areas in Diabetes (PAIDS) score is a self-report questionnaire that assesses diabetes burden and treatment. Scores range from 0 to 100, where higher scores indicate greater distress. For each participant, her baseline PAID score is subtracted from her month 6 PAID score to create a PAID change score. | The analysis population includes all women randomized to low dose or high dose therapy and completed the month 6 PAID assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | Systolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline systolic blood pressure is subtracted from her month 6 systolic blood pressure to create a systolic blood pressure change score. | The analysis population includes all women randomized to low dose or high dose therapy and completed the in-person month 6 study visit. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| Secondary | Change in Diastolic Blood Pressure From Baseline (Month 0) to Month 6 for the High Dose Cohort Versus Low Dose Cohort | Diastolic blood pressure is measured in millimeters of mercury (mmHg). For each participant, her baseline diastolic blood pressure is subtracted from her month 6 diastolic blood pressure to create a diastolic blood pressure change score. | The analysis population includes all women randomized to low dose or high dose therapy and completed the in-person month 6 study visit. | Posted | Mean | Standard Deviation | mmHg | Baseline and 6 months |
|
|
|
|
| 64 |
| 5 |
| 64 |
| 55 |
| 64 |
| EG001 | High Dose | 50,000 international units (IUs) weekly Vitamin D3 | 0 | 65 | 7 | 65 | 60 | 65 |
|
| Stroke | Nervous system disorders | Systematic Assessment | Stroke resulting in an inpatient hospitalization |
|
| Acoustic neuroma | Nervous system disorders | Systematic Assessment |
|
| Severe abdominal pain | Gastrointestinal disorders | Systematic Assessment | Severe abdominal pain resulting in inpatient hospitalization |
|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Unplanned pregnancy considered an important medical event |
|
| Left tibia fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Left tibia fracture resulting in an inpatient hospitalization |
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| Laparoscopic cholecystectomy | Surgical and medical procedures | Systematic Assessment | Unplanned laparoscopic cholecystectomy resulting in an inpatient hospitalization |
|
| Hiatal Hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hiatal hernia resulting in an inpatient hospitalization |
|
| Cancer Diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Right total knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unplanned right total knee replacement resulting in an inpatient hospitalization |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Generalized Pain | General disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Respiratory Symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Abnormal Kidney Function | Renal and urinary disorders | Systematic Assessment |
|
| Elevated Glucose | Metabolism and nutrition disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Routine Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Worsening Mood | Psychiatric disorders | Systematic Assessment |
|
| Worsening Diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
| Muscle Pain | General disorders | Systematic Assessment |
|
| Numbness | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Lower Extremity Cramps | General disorders | Systematic Assessment |
|
| Menstrual Symptoms | Reproductive system and breast disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Generalized Soreness | General disorders | Systematic Assessment |
|
| Swelling | General disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Hypertension | General disorders | Systematic Assessment |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |