How Much Vitamin D is Needed in Milk Products to Support Vitamin D Intake and Bone Health in Children?

NCT02097160 | Completed

• 1 other identifier: HW-14-01
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a parallel interventional randomized dose-response trial designed to improve vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will be recruited from the general population in the greater Montreal area. The study will be conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children will be required to attend two study visits. Some information will be collected through monthly telephone survey to the parents. The investigators will add vitamin D to cheese and yogurt for daily consumption at home over a three month period. All products will be provided to the parents in the form of coded containers that do not contain any labels aside from the group and expiration date. Ingredient lists will be provided upon consenting to the study. To better understand vitamin D status; dietary intake, hematology, serum biochemistry including 25(OH)D, growth, and body composition will be measured at the beginning and end of the three month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be documented and a skin pigmentation test will be used to more objectively assess chronic sun exposure. The investigators will also investigate the association between vitamin D intake and status with immune function.

Conditions

Healthy

Keywords

childhood; healthy; vitamin D; bone; dairy products

Outcome Measures

Primary Outcomes (1)

• 25(OH)D serum concentrations

  12 weeks

Study Arms (3)

Control Group 1

ACTIVE COMPARATOR

regular fortified milk + regular cheese/yogurt

Other: Control Group 1

Intervention Group 2

EXPERIMENTAL

Vitamin D fortified yogurt and cheese; vitamin D dose increment of 252 IU vs grp 1

Other: Vitamin D fortified yogurt and cheese products

Intervention Group 3

EXPERIMENTAL

Vitamin D fortified yogurt and cheese, vitamin D dose increment of 420 IU vs grp 1

Other: Vitamin D fortified yogurt and cheese products

Interventions

Vitamin D fortified yogurt and cheese products OTHER

Intervention Group 2; Intervention Group 3

Control Group 1 OTHER

Control Group 1

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children will be pre-pubertal
• Healthy
• Regularly consume milk and milk products
• Healthy weights
• All races will be studied.

You may not qualify if:

• Chronic diseases (including asthma) or medications known to affect vitamin D, infections or the immune system; known anaemia, small size at birth or preterm birth \<37 wk gestation
• No milk allergy or lactose intolerance, no nutritional supplements Less than 1/3rd of preschool age children take a supplement based on our work; it will thus not be a limitation for recruitment to exclude supplement users. We will not study obese children since the response to exogenous vitamin D intervention is reduced.

Sponsors & Collaborators

• McGill University: lead

Related Publications (1)

• Brett NR, Lavery P, Agellon S, Vanstone CA, Maguire JL, Rauch F, Weiler HA. Dietary vitamin D dose-response in healthy children 2 to 8 y of age: a 12-wk randomized controlled trial using fortified foods. Am J Clin Nutr. 2016 Jan;103(1):144-52. doi: 10.3945/ajcn.115.115956. Epub 2015 Dec 16.

  PMID: 26675772 DERIVED

Study Officials

• Hope A Weiler, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: March 26, 2014
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 11, 2014

Record last verified: 2014-11