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

NCT02656121 — Phase 2, Completed, 300 participants, Ain Shams University

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Registry	NCT02656121, acronym PCOSD
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	300 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	PCOS
Interventions	Vitamin D, Ovulatory Agent (Drug)
Dates	start 2016-02-01, primary completion 2018-11-01, completion 2018-11-01, first posted 2016-01-14, last updated 2018-11-16
Locations	1 site in Egypt

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Vitamin D	Experimental	Drug: Vitamin D; Drug: Ovulatory Agent	1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation
control	Active comparator	Drug: Ovulatory Agent	2nd subgroup will be treated with Clomophene Citrate only

Vitamin D (Drug), also known as Vidrop®, Medical Union Pharmaceuticals, Egypt: 6000 IU of vitamin D3
Ovulatory Agent (Drug), also known as Clomiphene Citrate for induction of ovulation: only Clomophine Citrate

+Outcome measures

Primary outcomes

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 outcomes

Cumlative clinical pregnancy rate [6 months]: detection of fetal heart activity detected by transvaginal ultrasound
median ovulating dose of clomiphene citrate [6 months]: Dose required

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Medicine, Ain Shams University	Cairo, Cairo Governorate	Egypt

+Investigators

Ahmed M kotb, MD, Principal investigator, Ain Shams University