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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02656121

Acronym

PCOSD

Enrollment

300

Registered

2016-01-14

Start date

2016-02-29

Completion date

2018-11-30

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS

Keywords

PCOS, vitamin D

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

Detailed 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

Interventions

DRUGVitamin D

6000 IU of vitamin D3

DRUGOvulatory Agent

only Clomophine Citrate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
cumulative clomiphene citrate-induced ovulation rates	6 months	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

Secondary

Measure	Time frame	Description
Cumlative clinical pregnancy rate	6 months	detection of fetal heart activity detected by transvaginal ultrasound
median ovulating dose of clomiphene citrate	6 months	Dose required

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026