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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Vitamin D Deficiency
• Interventions: Drug: Vitamin D3

• Registration Number: NCT03644212
• Lead Sponsor: Maimonides Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-05-04
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Results First Submitted: 2019-03-12
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Results First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D treatment	Vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
AMH Levels in Women With PCOS	8 weeks after completing vitamin D treatment	AMH measured by serum analysis

Trial Locations

Locations (1)

Maimonides Medical Center, OBGYN clinic; 🇺🇸 Brooklyn, New York, United States