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

NCT03644212 | Completed Phase 4 Results DMC

• 1 other identifier: 12/07/XA03
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• AMH Levels in Women With PCOS

  AMH measured by serum analysis

  8 weeks after completing vitamin D treatment

Study Arms (2)

Vitamin D treatment

ACTIVE COMPARATOR

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.

Drug: Vitamin D3

Non treated

NO INTERVENTION

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.

Interventions

Vitamin D3 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.

Also known as: Vitamin

Vitamin D treatment

Eligibility Criteria

• Age: 16 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Vitamin D deficient premenopausal women

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center, OBGYN clinic

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Vitamin D Deficiency

Interventions

Cholecalciferol; Vitamins

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Sara Meeder
• Organization: Maimonides Medical Center

smeeder@maimonidesmed.org

7182837253

Study Officials

• Mohamad Irani, MD

  Maimonides Medical Center, Brooklyn, NY, USA

  STUDY DIRECTOR

• Zaher Merhi, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2013
• First Posted: August 23, 2018
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2019-12

Locations

US (1)