Clinical Research Details

Descriptive Information
Effect of Vitamin D replacement on maternal and neonatal outcomes: a randomized controlled trial in pregnant women with hypovitaminosis D.

Ghada El-Hajj Fuleihan


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

  • Mona Nabulsi, MD, MSc
Maya Rahme
Extension: 01737868
Conditions and Keywords
Pregnant Women
Vitamin D,Middle East, Neonate,bone mineral content
Study Design
Efficacy Study
Double Blind
Eligibility and IRB
Min: 18
In Progress

 This study is a Phase III, randomized controlled, superiority trial, with two parallel groups, conducted in 2 centers. Participants, health care providers, data collectors, outcome adjudicator and biostatistician will be blinded to treatment allocation. Randomization will be performed as permuted block randomization with a 1:1 allocation

 This trial will be done in the Lebanese and other Middle Eastern populations, countries where vitamin D levels are reflective of the levels in the region. Recruitment will be done at the American University of Beirut-Medical center and RHUH Hospital, involving private clinics and Outpatient Department (OPD), allowing to include participants representing different regions and different socio-economic status.

 Pregnant women who consent to participate in the study will have a baseline blood test , at 11-13 weeks (during the routine nuchal translucency US visit). Recruitment:

Screened participants, fulfilling the inclusion criteria, will be called back and enrolled at 15-17 weeks.

Participants with 25(OH)D < 10 ng/ml will be referred for vitamin D replacement.

Inclusion criteria:

Pregnant women gestational age (GA)< 14 weeks at screening visit.

Middle Eastern woman

(Middle East countries defined by WHO: Bahrain, Egypt, Iran, Iraq, Palestine, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, , United Arab Emirates, Yemen)

 25(OH)D level between 10ng/ml and 30ng/ml,

For pregnant women with 25(OH)D below 10 ng/ml, it would be unethical to give low doses of vitamin D supplementation.

For pregnant women with 25(OH)D above 30ng/ml, vitamin D replacement with 600 IU daily are enough.

Age > 18 years

Vitamin D supplementation ≤200 IU daily*

*If daily vitamin D supplementation > 200 IU daily, at enrollment, the pregnant women will be advised to adjust prenatal multivitamin doses in such a way that total vitamin D supplementation per week doesn’t exceed 1400 IU per week, in consultation with primary OB-GYN.

 Exclusion criteria:

25(OH)D level < 10 ng/ml or > 30 ng/ml.

Known metabolic bone disease

Current medications likely to interfere with vitamin D metabolism (enzyme inducing anticonvulsants, anti –TB)

Vitamin D supplementation > 600IU daily

Fetal physical anomalies on the initial US

Renal stones


Uncontrolled thyroid dysfunction

Diagnosis of cancer in the last 10 years (other than basal cell carcinoma) 

Serum calcium >10mg/dl 

Diabetes mellitus type 1 or type 2

Previous gestational diabetes mellitus. 

Allergy to any component of vitamin D formulation