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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-11-30

Brief Summary

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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

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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

Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DRUG

6000 IU of vitamin D3

Ovulatory Agent

Intervention Type DRUG

only Clomophine Citrate

control

2nd subgroup will be treated with Clomophene Citrate only

Group Type ACTIVE_COMPARATOR

Ovulatory Agent

Intervention Type DRUG

only Clomophine Citrate

Interventions

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Vitamin D

6000 IU of vitamin D3

Intervention Type DRUG

Ovulatory Agent

only Clomophine Citrate

Intervention Type DRUG

Other Intervention Names

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Vidrop®, Medical Union Pharmaceuticals, Egypt Clomiphene Citrate for induction of ovulation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes