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

Tracking Information

First Received Date ^ICMJE

December 27, 2007

Last Updated Date

May 26, 2011

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00610688 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Vitamin D Deficiency

Intervention ^ICMJE

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
Drug: Cholecalciferol (Vitamin D3)
Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Study Arm (s)

Placebo Comparator: 1
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D

Intervention: Drug: Prenatal Vitamin
Experimental: 2
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
Interventions:
- Drug: Prenatal Vitamin
- Drug: Cholecalciferol (Vitamin D3)
Experimental: 3
Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
Interventions:
- Drug: Prenatal Vitamin
- Drug: Cholecalciferol (Vitamin D3)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.)

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, United Arab Emirates

Administrative Information

NCT Number ^ICMJE

NCT00610688

Other Study ID Numbers ^ICMJE

PA 03-103

Has Data Monitoring Committee

Yes

Responsible Party

Adekunle Dawodu, MBBS/Professor of Pediatrics, Director, International Patient Care & Education, Cincinnati Children's Hospital Medical Center

Study Sponsor ^ICMJE

Children's Hospital Medical Center, Cincinnati

Collaborators ^ICMJE

United Arab Emirates University
Thrasher Research Fund

Investigators ^ICMJE

Principal Investigator:	Adekunle Dawodu, MBBS	Children's Hospital Medical Center, Cincinnati
Principal Investigator:	Hussein F Saadi, MD	United Arab Emirates University

Information Provided By

Children's Hospital Medical Center, Cincinnati

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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