MedTrace Logo

Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes

NCT02434380 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-03-20

No results posted yet for this study

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.

Conditions

  • Hypovitaminosis D
  • Pregnancy Complications
  • Infant, Newborn, Diseases

Interventions

DIETARY_SUPPLEMENT

Euro D

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.

DIETARY_SUPPLEMENT

Euro D

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

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • Bahman Hospital Beirut Lebanon

    collaborator UNKNOWN

  • American University of Beirut Medical Center

    lead OTHER

Principal Investigators

  • Ghada El Hajj Fuleihan, Professor of Medicine · American University of Beirut Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Lebanon

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434380 on ClinicalTrials.gov