Trial Outcomes & Findings for Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial (NCT NCT03380091)
NCT ID: NCT03380091
Last Updated: 2021-02-09
Results Overview
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
TERMINATED
PHASE4
5 participants
Baseline & 12 weeks
2021-02-09
Participant Flow
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.
Participant milestones
| Measure |
Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
|
Overall Study
Began Arm Treatment
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
Baseline characteristics by cohort
| Measure |
Vitamin D (Cholecalciferol)
n=2 Participants
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
n=1 Participants
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Fasting Insulin
|
14.2 μIU/mL
STANDARD_DEVIATION 4.6 • n=5 Participants
|
32 μIU/mL
STANDARD_DEVIATION 0 • n=7 Participants
|
20.13 μIU/mL
STANDARD_DEVIATION 9.19 • n=5 Participants
|
|
Fasting Glucose
|
90.5 mg/dL
STANDARD_DEVIATION 3.5 • n=5 Participants
|
83 mg/dL
STANDARD_DEVIATION 0 • n=7 Participants
|
88 mg/dL
STANDARD_DEVIATION 4.54 • n=5 Participants
|
|
Fasting Insulin Resistance
|
3.12 units on a scale
STANDARD_DEVIATION 0.92 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
4.28 units on a scale
STANDARD_DEVIATION 1.80 • n=5 Participants
|
|
State-Trait Anxiety Inventory Score (STAI-S)
|
54.5 units on a scale
STANDARD_DEVIATION 3.5 • n=5 Participants
|
44 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
51 units on a scale
STANDARD_DEVIATION 5.71 • n=5 Participants
|
|
Vitamin D, 25 hydroxy
|
21.5 ng/mL
STANDARD_DEVIATION 2.5 • n=5 Participants
|
21 ng/mL
STANDARD_DEVIATION 0 • n=7 Participants
|
21.33 ng/mL
STANDARD_DEVIATION 2.05 • n=5 Participants
|
|
Beck Depression Inventory (BDI-II)
|
21.5 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
18 units on a scale
STANDARD_DEVIATION 0 • n=7 Participants
|
20.33 units on a scale
STANDARD_DEVIATION 4.02 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline & 12 weeksPopulation: 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.
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
Outcome measures
| Measure |
Vitamin D (Cholecalciferol)
n=1 Participants
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
n=1 Participants
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
|
-8 score on a scale
Standard Deviation 0
|
7 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline week & week 12Population: 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.
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.
Outcome measures
| Measure |
Vitamin D (Cholecalciferol)
n=1 Participants
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
n=1 Participants
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Changes From Baseline Week in Insulin Resistance Score at Week 12.
|
0.81 units on a scale
Standard Deviation 0
|
-1.2 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline week & Week 12Population: 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.
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
Outcome measures
| Measure |
Vitamin D (Cholecalciferol)
n=1 Participants
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
n=1 Participants
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
|
0 score on a scale
Standard Deviation 0
|
10 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline week & week 12Population: 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.
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
Outcome measures
| Measure |
Vitamin D (Cholecalciferol)
n=1 Participants
Cholecalciferol 5,000 IU PO daily
Vitamin D: Oral medication daily
|
Metformin
n=1 Participants
Metformin 1000 mg PO bid
Metformin: Oral medication daily
|
|---|---|---|
|
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
|
11 mg/dL
Standard Deviation 0
|
-5 mg/dL
Standard Deviation 0
|
Adverse Events
Vitamin D (Cholecalciferol)
Metformin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heather Huddleston
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place