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

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ClinicalTrials.gov Identifier: NCT03898934
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ayman S Dawood, MD, Tanta University

Tracking Information
First Submitted Date  ICMJE March 30, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Ovulation rate [ Time Frame: 3 months ]
    Number of mature follicles obtained
  • Pregnancy rate [ Time Frame: 3 months ]
    Number of patients who get pregnant
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03898934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Lean PCOS Patients
Official Title  ICMJE Dose Vitamin D Supplementation in Lean Patients With Polycystic Ovary Syndrome Improves Ovulation and Pregnancy Rates
Brief Summary To assess whether Vitamin D supplementations for lean patients with polycystic ovary syndrome in conjunction with clomiphene citrate are beneficial or not
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE PCOS
Intervention  ICMJE
  • Drug: Vitamin D
    receive 6000iu daily for 8 weeks
  • Drug: Placebo Oral Tablet
    placebo for the same period
Study Arms  ICMJE
  • Experimental: Vitamin D group
    These patients will receive 6000IU daily for 8 weeks then 2000IU maintenance till pregnancy or end of study
    Intervention: Drug: Vitamin D
  • Placebo Comparator: Placebo group
    These group will receive placebo for the same periods of study group
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ayman Dawood, MD +201020972067 ayman.dawood@med.tanta.edu.eg
Contact: Adel Elgergawy, MD +201002057250 dradelali775@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03898934
Other Study ID Numbers  ICMJE Lean Vitamin D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The investigators will share results
Supporting Materials: Study Protocol
Time Frame: 3 months
Responsible Party Ayman S Dawood, MD, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tanta University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP