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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380091
Recruitment Status : Terminated (Recruitment challenges)
First Posted : December 20, 2017
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
PCOS Depression Vitamin D Deficiency Insulin Resistance Drug: Metformin Drug: Vitamin D Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin, Vitamin D, and Depression in Polycystic Ovary Syndrome (PCOS) Trial: The MINDD Trial
Actual Study Start Date : December 12, 2017
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: Metformin
Metformin 1000 mg PO bid
Drug: Metformin
Oral medication daily

Experimental: Vitamin D (Cholecalciferol)
Cholecalciferol 5,000 IU PO daily
Drug: Vitamin D
Oral medication daily
Other Name: Cholecalciferol




Primary Outcome Measures :
  1. Depression [ Time Frame: 12-week study duration ]
    Symptoms of depression will be assessed by validated questionnaires


Secondary Outcome Measures :
  1. Insulin resistance [ Time Frame: 12-week study duration ]
    Lab testing will assess glucose and insulin homeostasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380091


Locations
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United States, California
UCSF Center for Reproductive Health
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Heather Huddleston, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03380091    
Other Study ID Numbers: 17-22550
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
PCOS
Depression
Vitamin D
Insulin Resistance
Anxiety
Quality of life
Mood disorders
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Vitamin D Deficiency
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Cholecalciferol
Metformin
Vitamins
Micronutrients
Nutrients
Growth Substances