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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2019-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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PCOS Depression Vitamin D Deficiency Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin 1000 mg PO bid

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Oral medication daily

Vitamin D (Cholecalciferol)

Cholecalciferol 5,000 IU PO daily

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

Oral medication daily

Interventions

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Metformin

Oral medication daily

Intervention Type DRUG

Vitamin D

Oral medication daily

Intervention Type DRUG

Other Intervention Names

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Glucophage Glucophage XR Fortamet Glumetza Cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes