CompletedPhase 3

Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes

Lebanon330 participantsStarted 2015-07

Plain-language summary

The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000 IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content at one month of age.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * 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 Obstetric and Gynecology (OB-GYN) physician.) 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 \> 600 IU daily * Pregnant women with twins

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml.

Timeframe: At delivery

Infant bone mineral content (BMC)

Timeframe: one to six weeks

Trial details

NCT IDNCT02434380

SponsorAmerican University of Beirut Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10

View on ClinicalTrials.gov More Hypovitaminosis D trials