Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial (MINDD)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Open-label randomized clinical trial assessing the efficacy of Metformin versus Vitamin D in improving symptoms of depressed mood in polycystic ovary syndrome.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal