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

PCOS Clinical Trial

— PCOSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656121
• Other study ID #: PCO
• Status: Completed
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• PCOS
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
6000 IU of vitamin D3
• Ovulatory Agent
only Clomophine Citrate

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative clomiphene citrate-induced ovulation rates	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	6 months
Secondary	Cumlative clinical pregnancy rate	detection of fetal heart activity detected by transvaginal ultrasound	6 months
Secondary	median ovulating dose of clomiphene citrate	Dose required	6 months