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

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: PCOS

Treatments: Drug: Vitamin D; Drug: Ovulatory Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT02656121

PCO

Details and patient eligibility

About

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

Full 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

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Ovulatory Agent

Drug: Vitamin D

control

Active Comparator group

Description:

2nd subgroup will be treated with Clomophene Citrate only

Treatment:

Drug: Ovulatory Agent