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

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ClinicalTrials.gov Identifier: NCT02656121
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

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
PCOS 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


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Study Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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 Name: Vidrop®, Medical Union Pharmaceuticals, Egypt

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




Primary Outcome Measures :
  1. cumulative clomiphene citrate-induced ovulation rates [ Time Frame: 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 [ Time Frame: 6 months ]
    detection of fetal heart activity detected by transvaginal ultrasound

  2. median ovulating dose of clomiphene citrate [ Time Frame: 6 months ]
    Dose required



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT02656121


Locations
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Egypt
Faculty of Medicine, Ain Shams University
Cairo, Al Qahirah, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Ahmed M kotb, MD Ain Shams University

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Responsible Party: Ahmed Mohamed El Kotb Abdel Fattah, Dr. Ahmed Kotb, Ain Shams University
ClinicalTrials.gov Identifier: NCT02656121     History of Changes
Other Study ID Numbers: PCO
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University:
PCOS, vitamin D

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents