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PCOSD: Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT02656121
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
33
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recently, a special emphasis has recently been directed to the potential role of vitamin D and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of PCOS and its related co-morbidities. The aim of this study was to assess the feasibility of conducting a pragmatic RCT assessing the effectiveness of adopting a protocol of screening for and correcting Vitamin D deficiency in women with PCOS seeking fertility treatment in a low/middle income care (LMIC) setting

Condition or Disease Intervention/Treatment Phase
  • Drug: Vitamin D
  • Drug: Ovulatory Agent
 Phase 2

Detailed Description

Research question:

In PCOS patients, is there any effect of vitamin D testing and correction on ovulation induction in women with PCOS?

Research hypothesis:

There is effect of testing and correcting vitamin D status as regard ovulation in patients with PCOS

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Correction of Vitamin D Deficiency and Its Effect on Ovulation Induction in Women With PCOS (VIDEO): A Feasibility RCT
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D

1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation

Drug: Vitamin D
6000 IU of vitamin D3
Other Names:
  • Vidrop®, Medical Union Pharmaceuticals, Egypt

    • Drug: Ovulatory Agent
    only Clomophine Citrate
    Other Names:
  • Clomiphene Citrate for induction of ovulation

    		•
    Active Comparator: control

    2nd subgroup will be treated with Clomophene Citrate only

    Drug: Ovulatory Agent
    only Clomophine Citrate
    Other Names:
  • Clomiphene Citrate for induction of ovulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cumulative clomiphene citrate-induced ovulation rates [6 months]

      Ultrasound Folliculometry was performed every other day starting on the 10th day of the induction cycle. Until, at least, one follicle reached 18mm in diameter

    Secondary Outcome Measures

    1. Cumlative clinical pregnancy rate [6 months]

      detection of fetal heart activity detected by transvaginal ultrasound

    2. median ovulating dose of clomiphene citrate [6 months]

      Dose required

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria
    Exclusion Criteria:
    • 1- PCOS patients not in child bearing age; less than 18 years or more than 45 years.

    2- Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.

    3- PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Ain Shams University Cairo Al Qahirah Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ahmed M kotb, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed El Kotb Abdel Fattah, Dr. Ahmed Kotb, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02656121
    Other Study ID Numbers:
    • PCO
    First Posted:
    Jan 14, 2016
    Last Update Posted:
    Nov 16, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Ahmed Mohamed El Kotb Abdel Fattah, Dr. Ahmed Kotb, Ain Shams University
    PCOS, vitamin D
    Additional relevant MeSH terms:
    Vitamin D Deficiency
    Vitamin D
    Clomiphene

    Study Results

    No Results Posted as of Nov 16, 2018