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

Stopped early · Phase 4

Conditions studied: PCOS, Depression, Vitamin D Deficiency, Insulin Resistance

In brief

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

Key facts

Study ID

NCT03380091

Run by

University of California, San Francisco

People needed

5

Starts

2017-12-12

Expected to finish

2019-09-01

Last updated by the study team

2021-02-09

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Center for Reproductive Health — San Francisco, California, United States

Full record on ClinicalTrials.gov

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