CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 330 target
Drug / intervention
Euro D +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02434380
NCT02434380Phase 3Completed
CompareCT.gov

Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes: a Randomized Controlled Trial in Pregnant Women With Hypovitaminosis D

American University of Beirut Medical Center·interventional·Posted May 5, 2015·Updated Mar 20, 2023

In Brief

A Phase 3 clinical trial evaluating Euro D for Hypovitaminosis D and 2 related conditions. Completed, enrolled 330 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypovitaminosis D, Pregnancy Complications, Infant, Newborn, Diseases
CountriesLebanon
CollaboratorsUniversity of Southampton, Bahman Hospital Beirut Lebanon

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartJul 1, 2015
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.2 years ago

Interventions

Euro Ddietary

Vitamin D3 Euro D 10,000 IU (1 tablet) plus Euro D Placebo (1 tablet) weekly, alternating with Euro D Placebo (2 tablets) weekly, starting at the second trimester and continued until delivery.

Euro Ddietary

Vitamin D3 Euro D 10,000 IU (2 tablets, equivalent to 20,000 IU) weekly, starting at the second trimester and continued until delivery.