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Vitamin D Supplementation in PCOS Patients (PCOvit-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. Read our disclaimer for details. Identifier: NCT03898934
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : May 5, 2022
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

Brief Summary:
To assess whether Vitamin D supplementations for 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 April 2019 to March 2022. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 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
Actual Primary Completion Date : March 30, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • 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

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 identifier (NCT number): NCT03898934

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Ayman Shehata Dawood
Tanta, Algharbia, Egypt, 31111
Sponsors and Collaborators
Tanta University
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Responsible Party: Ayman S Dawood, MD, Lecturer, Tanta University Identifier: NCT03898934    
Other Study ID Numbers: PCOvit-D
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
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:
Vitamin D
Additional relevant MeSH terms:
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Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents