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

November 10, 2014 updated by: Hope Weiler, McGill University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children will be pre-pubertal
  • Healthy
  • Regularly consume milk and milk products
  • Healthy weights

All races will be studied.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group 1
regular fortified milk + regular cheese/yogurt
Other: Control Group 1
Experimental: Intervention Group 2
Vitamin D fortified yogurt and cheese; vitamin D dose increment of 252 IU vs grp 1
Other: Vitamin D fortified yogurt and cheese products
Experimental: Intervention Group 3
Vitamin D fortified yogurt and cheese, vitamin D dose increment of 420 IU vs grp 1
Other: Vitamin D fortified yogurt and cheese products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
25(OH)D serum concentrations
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University

Investigators

  • Principal Investigator: Hope A Weiler, PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HW-14-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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