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

Sponsors and Collaborators:	Children's Hospital Medical Center, Cincinnati United Arab Emirates University Thrasher Research Fund
Information provided by:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00610688

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 III

MedlinePlus related topics: Prenatal Care

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Efficacy Study
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

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:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 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
2: Experimental 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
3: Experimental 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

Contacts

Contact: Hussein F Saadi, MD

+971-3-703-9651

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center	Active, not recruiting
Cincinnati, Ohio, United States, 45229
United Arab Emirates, Abu Dhabi
United Arab Emirated Unitersity	Recruiting
Al-Ain, Abu Dhabi, United Arab Emirates
Contact: Hussein F Saadi, MD +971-3-703-9651
Principal Investigator: Hussein F Saadi, MD

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:

Dawodu A, Agarwal M, Sankarankutty M, Hardy D, Kochiyil J, Badrinath P. Higher prevalence of vitamin D deficiency in mothers of rachitic than nonrachitic children. J Pediatr. 2005 Jul;147(1):109-11.

Dawodu A, Agarwal M, Hossain M, Kochiyil J, Zayed R. Hypovitaminosis D and vitamin D deficiency in exclusively breast-feeding infants and their mothers in summer: a justification for vitamin D supplementation of breast-feeding infants. J Pediatr. 2003 Feb;142(2):169-73.

Saadi HF, Dawodu A, Afandi BO, Zayed R, Benedict S, Nagelkerke N. Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women. Am J Clin Nutr. 2007 Jun;85(6):1565-71.

Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. No abstract available.

Responsible Party:	Cincinnati Children's Hospital Medical Center ( Adekunle Dawodu, MBBS/Professor of Pediatrics, Director, International Patient Care & Education )
Study ID Numbers:	PA 03-103
Study First Received:	December 27, 2007
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00610688
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; United Arab Emirates: General Authority for Health Services for Abu Dhabi

Study placed in the following topic categories:

Vitamin D Deficiency
Cholecalciferol
Vitamin D
Malnutrition
Avitaminosis

Rickets
Ergocalciferols
Nutrition Disorders
Deficiency Diseases

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs

Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009