NCT03644212

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: Female
• Age: 16 Years – 48 Years
• Healthy volunteers: Accepted

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.

Conditions

• Polycystic Ovary Syndrome
• Vitamin D Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2018-08-23
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

1 site across 1 country: United States