Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS

The purpose of this study is to investigate the mechanism that explain the beneficial clinical effect of vitamin D treatment in women with PCOS.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Avitaminosis Cysts Deficiency Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases Vitamin D Deficiency

Age range

16 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Maimonides Medical Center, OBGYN clinic

Brooklyn, New York, 11219, United States

About this study

Seventy-nine women with (n=22) or without (control; n=57) PCOS who were diagnosed with vitamin D deficiency were enrolled. Sixty-three women were treated with oral vit D3 for 8 weeks (16 with PCOS and 47 controls) and 16 women were not treated (6 with PCOS and 10 controls). Serum 25 hydroxy-vitamin D (25 OH-D), sRAGE, and AMH concentrations were measured at baseline and after vit D3 supplementation in the treated group, and 8 weeks apart in the non-treated group. Paired t-test, Wilcoxon signed-rank test, and Pearson correlation were used as appropriate.

Main outcome measure: Changes in AMH concentrations following vit D3 replacement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Vitamin D deficient premenopausal women

Exclusion criteria

Pregnant women
Women during their postpartum period
Breastfeeding women
Women taking any kind of exogenous hormones
Women receiving any form of oral vitamin D replacement

Treatment and study plan

Vitamin D3

Drug

Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.

Other names: Vitamin

Primary outcomes

AMH Levels in Women With PCOS

Time frame: 8 weeks after completing vitamin D treatment

AMH measured by serum analysis

Sponsors and collaborators

Lead sponsor

Maimonides Medical Center

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Aug 23, 2018
Registry last updated: Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed