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

NCT00846677 | Completed Phase 4

• 1 other identifier: PLB-D301
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Infants; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Parental and infant preference for a new vitamin D delivery system over the standard of care supplement in syrup form.

  21 days

Secondary Outcomes (1)

• Barriers to either supplement delivery system being given during infancy.

  21 days

Study Arms (2)

1

EXPERIMENTAL

Vitamin D quick dissolve strip

Dietary Supplement: Vitamin D, cholecalciferol

2

ACTIVE COMPARATOR

Vitamin D syrup

Dietary Supplement: Vitamin D, cholecalciferol

Interventions

Vitamin D, cholecalciferol DIETARY_SUPPLEMENT

Oral Quick Dissolve Strip, 400 IU once per day for 21 days

Also known as: BabyVita Vitamin D

1

Eligibility Criteria

• Age: 2 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit

Sainte-Anne-de-Bellevue, Quebec, H9X 3V9, Canada

Location

Related Publications (1)

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hope A Weiler, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

CA (1)