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Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial (MINDD)

Primary Purpose

PCOS, Depression, Vitamin D Deficiency

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin
Vitamin D
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS focused on measuring PCOS, Depression, Vitamin D, Insulin Resistance, Anxiety, Quality of life, Mood disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
  • Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
  • Insulin resistance
  • Mild or greater severity of depression by Beck Depression Inventory-II

Exclusion Criteria:

  • Current metformin use
  • Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
  • Insulin-dependent diabetes mellitus
  • Pregnancy or breastfeeding
  • Untreated hypothyroidism
  • Current active substance abuse
  • Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Sites / Locations

  • UCSF Center for Reproductive Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metformin

Vitamin D (Cholecalciferol)

Arm Description

Metformin 1000 mg PO bid

Cholecalciferol 5,000 IU PO daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
December 15, 2017
Last Updated
January 21, 2021
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03380091
Brief Title
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial
Acronym
MINDD
Official Title
Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Depression, Vitamin D Deficiency, Insulin Resistance
Keywords
PCOS, Depression, Vitamin D, Insulin Resistance, Anxiety, Quality of life, Mood disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin 1000 mg PO bid
Arm Title
Vitamin D (Cholecalciferol)
Arm Type
Experimental
Arm Description
Cholecalciferol 5,000 IU PO daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage, Glucophage XR, Fortamet, Glumetza
Intervention Description
Oral medication daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Oral medication daily
Primary Outcome Measure Information:
Title
Change From Baseline in Depression Score on the Beck Depression Inventory (BDI-II) at 12 Weeks
Description
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
Time Frame
Baseline & 12 weeks
Secondary Outcome Measure Information:
Title
Changes From Baseline Week in Insulin Resistance Score at Week 12.
Description
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.
Time Frame
Baseline week & week 12
Title
Change From Baseline in State-Trait Anxiety Inventory Score (STAI-S) at 12 Weeks
Description
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
Time Frame
Baseline week & Week 12
Title
Changes From Baseline Week in Vitamin D 25-hydroxy Levels at Week 12.
Description
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
Time Frame
Baseline week & week 12

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria) Vitamin D insufficiency (serum Vitamin D <30 ng/mL) Insulin resistance Mild or greater severity of depression by Beck Depression Inventory-II Exclusion Criteria: Current metformin use Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency Insulin-dependent diabetes mellitus Pregnancy or breastfeeding Untreated hypothyroidism Current active substance abuse Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Huddleston, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Center for Reproductive Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial

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