ClinicalTrials.Veeva

Menu

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

A

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

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems