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Recruitment challenges
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Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
This is a single center, open-label, randomized, pilot clinical trial. Women with polycystic ovary syndrome and depressed mood, who are insulin resistant and vitamin D insufficient are eligible. Subjects are randomly assigned to one of two interventions: Vitamin D versus metformin. Subjects are followed with questionnaires and a final wrap-up clinic visit with a physician. The study duration is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental | Metformin 1000 mg PO bid |
|
| Vitamin D (Cholecalciferol) | Experimental | Cholecalciferol 5,000 IU PO daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Oral medication daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks | BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score | Baseline & 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline Week in Insulin Resistance Score at Week 12. | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Heather Huddleston, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Center for Reproductive Health | San Francisco | California | 94158 | United States |
Of the 5 participants that were enrolled in the trial, all were randomized and assigned to treatment arms. 3 were assigned to the Vitamin D supplement arm and 2 were assigned to the Metformin arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D (Cholecalciferol) | Cholecalciferol 5,000 IU PO daily Vitamin D: Oral medication daily |
| FG001 | Metformin | Metformin 1000 mg PO bid Metformin: Oral medication daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Although 3 participants were assigned to Vitamin D, one dropped out just after enrollment and arm assigment and another dropped out after completing baseline time point measures, thus only one participant in the Vitamin D arm had data available for outcome measures analysis. Although 2 participants were assigned to Metformin, one dropped out just after enrollment and arm assignment, thus only one participant in the Metformin arm had data available for outcome measures analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D (Cholecalciferol) | Cholecalciferol 5,000 IU PO daily Vitamin D: Oral medication daily |
| BG001 | Metformin | Metformin 1000 mg PO bid Metformin: Oral medication daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks | BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. Change = Week 12 total score - Baseline week score | In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Depression from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available. | Posted | Mean | Standard Deviation | score on a scale | Baseline & 12 weeks |
|
Study activity participation window of 12 weeks.
AE and SAE definition meet clinicaltrials.gov definitions
Investigators will carefully track serious adverse events and all of these events will be reported to the DSM at scheduled meetings. Grade 4 adverse events will be reported to the DSM within 24 hours of receipt by the Study Coordinator. Adverse events meeting IRB reporting criteria (adverse event that are definitely, probably, or possibly related to the research AND serious OR unexpected) will be reported within 5 working days.
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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 | Vitamin D (Cholecalciferol) | Cholecalciferol 5,000 IU PO daily Vitamin D: Oral medication daily |
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Feasibility of recruitment and participant completion determined to be too low to continue the study and the trial was terminated early, resulting in only 2 of the 5 enrolled participants completing the trial. This lead to only two subjects will full data and one subject with partial data being analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Huddleston | University of California, San Francisco | (415) 353-3040 | Heather.Huddleston@ucsf.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 | Oct 2, 2019 | Dec 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D014808 | Vitamin D Deficiency |
| D007333 | Insulin Resistance |
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D012632 |
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| Vitamin D | Drug | Oral medication daily |
|
|
| Baseline week & week 12 |
| Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks | STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score | Baseline week & Week 12 |
| Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12. | Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated. Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient <20ng/mL | Baseline week & week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 |
|
| Fasting Insulin | Fasting blood insulin levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention Optimal Reference range: Fasting 2.0-19.6 μIU/mL | Mean | Standard Deviation | μIU/mL |
|
| Fasting Glucose | Fasting blood glucose levels were assayed by Quest Diagnostics. Time point: Baseline, pre-intervention Optimal Reference range: Fasting 65-99 mg/dL | Mean | Standard Deviation | mg/dL |
|
| Fasting Insulin Resistance | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnositcs. Time point: Baseline, pre-intervention HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance. | Mean | Standard Deviation | units on a scale |
|
| Vitamin D, 25 hydroxy | Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Time period: baseline, pre-intervention Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient <20ng/mL | Mean | Standard Deviation | ng/mL |
|
| Beck Depression Inventory (BDI-II) | BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. Time period: baseline; pre-intervention Score ranges: {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression}. | Mean | Standard Deviation | units on a scale |
|
| State-Trait Anxiety Inventory Score (STAI-S) | STAI-S is a validated self-reported instrument of 20 questions. Time period: baseline, pre-intervention Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms | Mean | Standard Deviation | units on a scale |
|
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
| OG001 | Metformin | Metformin 1000 mg PO bid Metformin: Oral medication daily |
|
|
| Secondary | Changes From Baseline Week in Insulin Resistance Score at Week 12. | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) will be used to calculate Insulin Resistance based on fasting glucose (mg/dL) and fasting insulin (μIU/mL) blood serum assays tested at Quest Diagnostics. HOMA-IR = Fasting Insulin (uIU/mL) x Fasting Glucose (mg/dL). Healthy range is between 0.5-1.4. Values below 1.0 indicate insulin sensitivity and are optimal. Values greater than 1.9 indicate clinically significant insulin resistance. | In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Insulin Resistance from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum insulin and glucose test results were available. | Posted | Mean | Standard Deviation | units on a scale | Baseline week & week 12 |
|
|
|
| Secondary | Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks | STAI-S is a validated self-reported instrument of 20 questions. Range of scores for the State Anxiety (STAI-S) subtest is 20-80, the higher score indicating greater anxiety. A threshold point score of 39-40 has been suggested by recent literature to detect clinically significant symptoms. Change = Week 12 total score - Baseline week score | In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for a Change in Anxiety scores from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 scores were available. | Posted | Mean | Standard Deviation | score on a scale | Baseline week & Week 12 |
|
|
|
| Secondary | Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12. | Vitamin D, 25-hydroxy blood serum assays will be tested at Quest Diagnostics. Changes in values from baseline week to week 12 will be calculated. Reference ranges: optimal 30-100 ng/mL Insufficient 20-29 ng/mL deficient <20ng/mL | In both the Vitamin D and the Metformin arms, only 1 participant in each arm was analyzed for Change in Vitamin D serum levels from Baseline as only 1 participant in each arm participated through to week 12. A Change could not be calculated for the other 3 participants as no week 12 serum Vitamin D test results were available. | Posted | Mean | Standard Deviation | mg/dL | Baseline week & week 12 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Metformin | Metformin 1000 mg PO bid Metformin: Oral medication daily | 0 | 2 | 0 | 2 | 0 | 2 |
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| D044342 |
| Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001523 | Mental Disorders |
| Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |