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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644212
• Other study ID #: 12/07/XA03
• Status: Completed
• Phase: Phase 4
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2019
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Vitamin D Deficiency

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Maimonides Medical Center, OBGYN clinic	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH Levels in Women With PCOS	AMH measured by serum analysis	8 weeks after completing vitamin D treatment