Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips - Full Text View

Sponsored by:	McGill University
Information provided by:	McGill University
ClinicalTrials.gov Identifier:	NCT00846677

Purpose

Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.

There is little data about adherence to supplementation in Canada, but one study shows that in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave their infant vitamin D supplements in the first six months and 62.1 % of those feeding formula did not. For the Canadian situation, it is not clear if the modality of the supplementation is a barrier to providing the supplement. Thus the overall aim of this study is to test a new delivery system for parental preference and infant acceptance compared to a standard vitamin D supplement.

Condition	Intervention	Phase
Healthy	Dietary Supplement: Vitamin D, cholecalciferol	Phase IV

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Official Title:	A Randomized, Open-Label, Cross-Over Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips.

Further study details as provided by McGill University:

Primary Outcome Measures:

Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Barriers to either supplement delivery system being given during infancy. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vitamin D quick dissolve strip	Dietary Supplement: Vitamin D, cholecalciferol Oral Quick Dissolve Strip, 400 IU once per day for 21 days
2: Active Comparator Vitamin D syrup	Dietary Supplement: Vitamin D, cholecalciferol Oral Syrup, 400IU per day for 21 days

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 4 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy singleton newborn infants born at term age of any racial background.
Infants may be breastfed or formula fed during the study as is safe since the supplement is 400 IU/d and intakes from breast milk or formula will not exceed 400 IU/d for a theoretical total intake of 800 IU/d that is recommended by the Canadian Pediatric Society.

Exclusion Criteria:

Infants born prematurely, twins or other multiples.
Unable to nurse or accept the supplement.
Congenital malformations.
Parents not fluent enough in English or French to provide written informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846677

Contacts

Contact: Hope A Weiler, PhD

514-398-7905

hope.weiler@mcgill.ca

Locations

Canada, Quebec
Mary Emily Clinical Nutrition Research Unit	Recruiting
Sainte Anne de Bellevue, Quebec, Canada, H9X 3V9
Contact: Catherine A Vanstone, RN, MSc 514-398-7527 Catherine.vanstone@mcgill.ca
Principal Investigator: Hope A Weiler, PhD

Sponsors and Collaborators

McGill University

Investigators

Principal Investigator:

Hope A Weiler, PhD

McGill University

More Information

No publications provided

Responsible Party:	McGill University ( Dr. Hope Weiler / Associate Professor )
Study ID Numbers:	PLB-D301
Study First Received:	February 17, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00846677 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McGill University:

Healthy
Infants
Vitamin D

Study placed in the following topic categories:

Cholecalciferol
Vitamin D
Vitamins
Bone Density Conservation Agents

Trace Elements
Micronutrients
Healthy

Additional relevant MeSH terms:

Cholecalciferol
Vitamin D
Growth Substances
Vitamins

Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009