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

NCT02656121 | Completed Phase 2 DMC

• 1 other identifier: PCO
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

PCOS

Keywords

PCOS, vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumlative clinical pregnancy rate

  6 months

• median ovulating dose of clomiphene citrate

  6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Drug: Vitamin D; Drug: Ovulatory Agent

control

ACTIVE COMPARATOR

2nd subgroup will be treated with Clomophene Citrate only

Drug: Ovulatory Agent

Interventions

Vitamin D DRUG

6000 IU of vitamin D3

Also known as: Vidrop®, Medical Union Pharmaceuticals, Egypt

Vitamin D

Ovulatory Agent DRUG

only Clomophine Citrate

Also known as: Clomiphene Citrate for induction of ovulation

Vitamin D; control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

You may not qualify if:

• PCOS patients not in child bearing age; less than 18 years or more than 45 years.
• Patients with congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors.
• PCOS patients with any other medical illness. 4- PCOS patients already on vitamin D supplements.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Vitamin D; Clomiphene; Ovulation Induction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed M kotb, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ahmed Kotb

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)