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

NCT ID: NCT03644212

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Polycystic Ovary Syndrome; Vitamin D Deficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D treatment

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: 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.

Non treated

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Vitamin

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamad Irani, MD

Role: STUDY_DIRECTOR

Maimonides Medical Center, Brooklyn, NY, USA

Zaher Merhi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont College of Medicine, Burlington, VT, USA

Locations

Maimonides Medical Center, OBGYN clinic

Brooklyn, New York, United States

Countries

United States

Other Identifiers

12/07/XA03

Identifier Type: -

Identifier Source: org_study_id