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

• Status: Terminated
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Cholecalciferol; Metformin; Vitamin D

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