Summary

for females ages 18-45 (full criteria)
healthy people welcome
at San Francisco, California
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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.

Keywords

PCOS Depression Vitamin D Deficiency Insulin Resistance Vitamin D Anxiety Quality of life Mood disorders Depressive Disorder Polycystic Ovary Syndrome Vitamins Ergocalciferols Cholecalciferol Metformin Vitamin D (Cholecalciferol)

Eligibility

You can join if…

Open to females ages 18-45

  • 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 CAN'T join 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

Location

  • UCSF Center for Reproductive Health accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03380091
Phase
Phase 4
Study Type
Interventional
Last Updated