Vitamin D for the Treatment of Women With Polycystic Ovary Syndrome (PCOS)

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if vitamin D will improve insulin resistance, inflammation, and overall well-being in women with PCOS.

Clinical Trial Description

As many cells throughout the body possess the vitamin D receptor, adequate vitamin D levels may be essential for multiple physiologic functions. In recent years, vitamin D insufficiency has been linked to insulin resistance, inflammation, poor psychological health, obesity, type 2 diabetes, and cardiovascular disease - these are also commonly found in women with Polycystic Ovary syndrome (PCOS). We believe that vitamin D insufficiency contributes to insulin resistance, inflammation, and psychological distress in women with PCOS. These adverse effects may ultimately increase the risk for serious long-term complications in PCOS, including type 2 diabetes and cardiovascular disease. The key objectives of this research study are to determine the effects of vitamin D supplementation on insulin resistance, inflammation, mood and overall well-being in women with PCOS.

The protocol has been modified by adding the following specific aim: To compare vascular function in healthy age and BMI similar matched women to PCOS women pre-treatment. Our hypothesis is that PCOS women will have greater attenuations in retinal vascular reactivity compared to healthy control women, demonstrating poorer endothelial function. We are currently recruiting healthy women who are age and BMI similar to the PCOS women and measure their retinal vascular reactivity for comparisons to the PCOS women's pre-treatment vascular reactivity. These healthy women will only have a baseline visit in which retinal vascular reactivity will be measured. They will not be enrolled in the placebo or Vitamin D randomization process as described above. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00907153
Study type	Interventional
Source	Milton S. Hershey Medical Center
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 2009
Completion date	September 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03142633` - MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Completed	`NCT06158932` - A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Active, not recruiting	`NCT02500147` - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)	Phase 4
Completed	`NCT04932070` - Berberine and Polycystic Ovary Syndrome	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT03480022` - Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS	Phase 3
Active, not recruiting	`NCT03043924` - Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT05246306` - Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
Completed	`NCT05981742` - Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	Phase 2
Completed	`NCT05702957` - Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome	Phase 2/Phase 3
Completed	`NCT05029492` - Effect of Visceral Manipulation on PCOS	N/A
Completed	`NCT02924025` - Motivational Interviewing as an Intervention for PCOS	N/A
Not yet recruiting	`NCT02255578` - Endobarrier Treatment in Women With PCOS	Phase 3
Completed	`NCT02098668` - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	N/A
Not yet recruiting	`NCT00883259` - Metformin and Gestational Diabetes in High-risk Patients: a RCTs	Phase 4
Withdrawn	`NCT01638988` - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin	Phase 3
Completed	`NCT01462864` - Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome	N/A
Recruiting	`NCT01431352` - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)	N/A
Completed	`NCT00989781` - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome	N/A