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

• Sponsor: Maimonides Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03644212
• Collaborator: (none)
• Enrollment: 79
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 5.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Vitamin D Deficiency	Drug: Vitamin D3	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vitamin D Increases Serum Levels of the Soluble Receptor for Advanced Glycation End Products in Women With PCOS
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.; Other Names: Vitamin
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. AMH Levels in Women With PCOS [8 weeks after completing vitamin D treatment]

   AMH measured by serum analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 48 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center, OBGYN clinic	Brooklyn	New York	United States	11219

Sponsors and Collaborators

• Maimonides Medical Center

Investigators

• Study Director: Mohamad Irani, MD, Maimonides Medical Center, Brooklyn, NY, USA
• Principal Investigator: Zaher Merhi, MD, University of Vermont College of Medicine, Burlington, VT, USA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT03644212
• Other Study ID Numbers: 12/07/XA03
• First Posted: Aug 23, 2018
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Maimonides Medical Center: Polycystic Ovary Syndrome; Vitamin D; Anti Mullerian Hormone; Soluble receptor for Advanced Glycation End Products
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Vitamin D Deficiency; Vitamin D; Cholecalciferol; Vitamins

Study Results

Participant Flow

Arm/Group Title	Vitamin D Treatment	Non Treated
Arm/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. 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.	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.
Period Title: Overall Study
STARTED	63	16
COMPLETED	63	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Vitamin D Treatment	Non Treated	Total
Arm/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. 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.	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.	Total of all reporting groups
Overall Participants	63	16	79
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	63 100%	16 100%	79 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	63 100%	16 100%	79 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	63 100%	16 100%	79 100%

Outcome Measures

1. Primary Outcome

Title	AMH Levels in Women With PCOS
Description	AMH measured by serum analysis
Time Frame	8 weeks after completing vitamin D treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vitamin D Treatment	Non Treated
Arm/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. 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.	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.
Measure Participants	63	16
Mean (Standard Deviation) [ng/mL]	1.4 (0.55)	0 (0.5)

Adverse Events

Time Frame	Adverse event data was collected throughout the 8 weeks of the study.
Arm/Group Title	Vitamin D Treatment		Non Treated
Arm/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. 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.		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.
All Cause Mortality
	Vitamin D Treatment		Non Treated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vitamin D Treatment		Non Treated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Vitamin D Treatment		Non Treated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.