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

Primary Purpose

Polycystic Ovary Syndrome, Vitamin D Deficiency

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Vitamin D, Anti Mullerian Hormone, Soluble receptor for Advanced Glycation End Products

Eligibility Criteria

16 Years - 48 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

Maimonides Medical Center, OBGYN clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Vitamin D treatment

Non treated

Arm 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.

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.

Outcomes

Primary Outcome Measures

AMH Levels in Women With PCOS

AMH measured by serum analysis

Secondary Outcome Measures

Full Information

NCT ID

NCT03644212

First Posted

May 4, 2013

Last Updated

December 30, 2019

Sponsor

Maimonides Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03644212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maimonides Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Vitamin D Deficiency

Keywords

Polycystic Ovary Syndrome, Vitamin D, Anti Mullerian Hormone, Soluble receptor for Advanced Glycation End Products

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D treatment

Arm Type

Active Comparator

Arm Description

Arm Title

Non treated

Arm Type

No Intervention

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Vitamin

Intervention Description

Primary Outcome Measure Information:

Title

AMH Levels in Women With PCOS

Description

AMH measured by serum analysis

Time Frame

8 weeks after completing vitamin D treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

48 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad Irani, MD

Organizational Affiliation

Maimonides Medical Center, Brooklyn, NY, USA

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zaher Merhi, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maimonides Medical Center, OBGYN clinic

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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