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

PCOSDepressionVitamin D DeficiencyInsulin ResistanceVitamin DAnxietyQuality of lifeMood disordersDepressive DisorderPolycystic Ovary SyndromeVitaminsErgocalciferolsCholecalciferolMetforminVitamin 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 Healthaccepting new patients
    San FranciscoCalifornia94158United 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