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Vitamin D Supplementation in Lean PCOS Patients (Leanvit-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898934
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

Study Description
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Brief Summary:
To assess whether Vitamin D supplementations for lean patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not

Condition or disease Intervention/treatment Phase
PCOS Drug: Vitamin D Drug: Placebo Oral Tablet Phase 4

Detailed Description:
This study is double blinded randomized controlled study conducted at Tanta University hospitals in the period from September 2017 to December 2018. Patients and methods: One hundred twelve patients were recruited and randomly allocated into 2 groups; study group with Vitamin D supplementation and control group without Vitamin D supplementation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The 2 groups will be treated at the same time
Masking: Double (Participant, Care Provider)
Masking Description: Both patients and gynecologists were binded
Primary Purpose: Treatment
Official Title: Dose Vitamin-D Supplementation Affect Reproductive Outcomes in Patients With Polycystic Ovary Syndrome?
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vitamin D group
These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study
 Drug: Vitamin D
receive 6000iu daily for 8 weeks
Placebo Comparator: Placebo group
These group will receive placebo for the same periods of study group
 Drug: Placebo Oral Tablet
placebo for the same period


Outcome Measures
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Primary Outcome Measures :
  1. Ovulation rate [ Time Frame: 3 months ]
    Number of mature follicles obtained

  2. Pregnancy rate [ Time Frame: 3 months ]
    Number of patients who get pregnant


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lean
  • PCOS
  • Infertile
  • Vitamin D deficient

Exclusion Criteria:

  • Age less than 20 and more than 35
  • Non PCOS patients
  • Obese patients
  • Previous ovarian surgery
  • Previous oophrectomy of one ovary
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898934


Contacts
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Contact: Ayman Dawood, MD +201020972067 ayman.dawood@med.tanta.edu.eg
Contact: Adel Elgergawy, MD +201002057250 dradelali775@gmail.com

Locations
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Egypt
Ayman Shehata Dawood Recruiting
Tanta, Algharbia, Egypt, 31111
Contact: Ahmed Elhalwagy, MD    +201020972067    halwagy22@yahoo.com   
Contact: Hesham Salem, MD    +20122348805    prof.hesham_salem@hotmail.com   
Ayman Shehata Dawood Recruiting
Tanta, Algharbia, Egypt, 31111
Contact: Salah Naglah, MD       salahnaglah@yahoo.com   
Contact: Adel Elgergawy, MD    01002057250 ext 002    dradelali775@gmail.com   
Sponsors and Collaborators
Tanta University
More Information
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Responsible Party: Ayman S Dawood, MD, Lecturer, Tanta University
ClinicalTrials.gov Identifier: NCT03898934    
Other Study ID Numbers: Lean Vitamin D
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will share results
Supporting Materials: Study Protocol
Time Frame: 3 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayman S Dawood, MD, Tanta University:
Lean PCOS
Vitamin D
Supplementation
Ovulation
Pregnancy
Additional relevant MeSH terms:
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Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents