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

Phase 2

Completed

• Conditions: PCOS
• Interventions: Drug: Vitamin D; Drug: Ovulatory Agent

• Registration Number: NCT02656121
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-14
• Study Start: 2016-02
• Status Verified: 2018-11
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Ovulatory Agent	1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation
control	Ovulatory Agent	2nd subgroup will be treated with Clomophene Citrate only
Vitamin D	Vitamin D	1st subgroup will be tested and treated with vitamin D together with Clomiphene Citrate for induction of ovulation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
median ovulating dose of clomiphene citrate	6 months	Dose required
Cumlative clinical pregnancy rate	6 months	detection of fetal heart activity detected by transvaginal ultrasound

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt