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Completed

NCT Number: NCT00610688

Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

United Arab Emirated Unitersity, Al Ain City, Abu Dhabi Emirate, United Arab Emirates

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About this study

Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women who are within the ages of 18-45 years
  • In good general health
  • 12 weeks pregnant (based on last menstrual period)

Exclusion criteria

  • Mothers with preexisting type I or type II diabetes
  • Mothers with preexisting hypertension
  • Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
  • Mothers with multiple fetuses (e.g., twins, triplets, etc.)

Treatment and study plan

Prenatal Vitamin

Drug

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

cholecalciferol (vitamin D3)

Drug

Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery

Primary outcomes

  1. Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement

    Time frame: 12, 16, 28 weeks and at maternal delivery and neonatal birth

    Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement

Secondary outcomes

  1. Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth

    Time frame: At delivery

    Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth

  2. Birthweight of Newborn Infant

    Time frame: Measured at birth.

    Growth of the Newborn Infant as Measured by Birthweight in grams.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Thrasher Research Fund
  • United Arab Emirates University

Registry information

Official study title

High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

Acronym: PA 03-103

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 8, 2008
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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