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

This study has been completed.
Sponsor:
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00610688
First received: December 27, 2007
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Drug: Prenatal Vitamin
Drug: Cholecalciferol (Vitamin D3)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement [ Time Frame: 29 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth

  • Birthweight of Newborn Infant [ Time Frame: Measured at birth. ] [ Designated as safety issue: No ]
    Growth of the Newborn Infant as Measured by Birthweight in grams.


Enrollment: 192
Study Start Date: January 2008
Study Completion Date: April 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Prenatal Vitamin D3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Experimental: 2
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3)
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Drug: Cholecalciferol (Vitamin D3)
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Experimental: 3
Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3).
Drug: Prenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Drug: Cholecalciferol (Vitamin D3)
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610688

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United Arab Emirates
United Arab Emirated Unitersity
Al-Ain, Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
United Arab Emirates University
Thrasher Research Fund
Investigators
Principal Investigator: Adekunle Dawodu, MBBS Children's Hospital Medical Center, Cincinnati
Principal Investigator: Hussein F Saadi, MD United Arab Emirates University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00610688     History of Changes
Other Study ID Numbers: PA 03-103
Study First Received: December 27, 2007
Results First Received: May 15, 2012
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United Arab Emirates: General Authority for Health Services for Abu Dhabi

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014