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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03380091
Other study ID # 17-22550
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date December 12, 2017
Est. completion date September 1, 2019

Study information

Verified date January 2021
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Metformin
Oral medication daily
Vitamin D
Oral medication daily

Locations

Country Name City State
United States UCSF Center for Reproductive Health San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 Baseline & 12 weeks
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. 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 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
Baseline week & week 12
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