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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
United Arab Emirates University
Thrasher Research Fund
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00610688
First received: December 27, 2007
Last updated: May 26, 2011
Last verified: May 2011
History of Changes
  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 maintaining normal vitamin D blood levels during pregnancy and in newborn infants.


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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Maternal and neonatal serum 25-hydroxyvitamin D measurement [ Time Frame: 29 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Growth of the newborn infant as measured by weight, crown-heel length and head circumference at birth [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Arm will receive prenatal vitamin with 400IU of Vitamin D 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 Vitamin D along with a tablet containing 1600IU of Vitamin D
 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 Vitamin D along with a tablet containing 3600IU of Vitamin D
 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

  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
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:

Responsible Party: Adekunle Dawodu, MBBS/Professor of Pediatrics, Director, International Patient Care & Education, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00610688     History of Changes
Other Study ID Numbers: PA 03-103
Study First Received: December 27, 2007
Last Updated: May 26, 2011
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
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013