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

Maimonides Medical Center

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency; Polycystic Ovary Syndrome

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03644212

12/07/XA03

Details and patient eligibility

About

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

Full 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.

Enrollment: 79 patients

Sex: Female

Ages: 16 to 48 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

79 participants in 2 patient groups

Vitamin D treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Vitamin D3

Non treated

No Intervention group

Description:

Sixteen vitamin D deficient women (6 with PCOS and 10 without PCOS) were not supplemented vitamin D3. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.