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Fortified Cheese and Yogurt Products and Vitamin D Status in Young Children? Phase 2

NCT02387892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-11-06

No results posted yet for this study

Summary

This study is being done to test if adding vitamin D to cheese and yogurt products will help children further improve their vitamin D intake. All children will be given a six month supply of the milk products. One group will receive yogurt and cheese products already sold in stores, while the other group will receive yogurt and cheese products with added vitamin D. This will show if milk products with added vitamin D help maintain vitamin D intake and child health.

The investigators are asking children 2 through 8 years old to participate. Children must not have any medical conditions that affect their bones or vitamin D levels. They must not be taking vitamin D supplements or medications that affect bone. This study will last for 6 months. The investigators expect 60 children from the Montreal area will participate in this study.

Children will be randomly placed in one of the two study groups. There will be an equal number of children in each group. All groups will go through the exact same procedures during the study; the only difference between groups will be the amount of vitamin D in the milk products they will consume each day. Families will not know which group their child is in until the study is complete. Children will continue to drink their regular milk at home and the investigators will provide flavoured yogurts and cheese to eat every day for the entire 6 month study. Families will be given a fresh supply of the yogurt or cheese products every 4 weeks along with instructions.

There are 3 study meetings for the parent and child to attend which take place at the Mary Emily Clinical Nutrition Research Unit. The clinic is located on the Macdonald Campus of McGill University in Ste. Anne-de-Bellevue, QC. The first visit is at the start of the study, the second is at the end of 3 months and the last visit is at the end of the 6 month study.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Cheese & yogurt + Vitamin D

cheese \& yogurt with added 420 IU cholecalciferol

DIETARY_SUPPLEMENT

Cheese & yogurt

Cheese \& yogurt without added vitamin D

Sponsors & Collaborators

Principal Investigators

  • Hope A Weiler, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02387892 on ClinicalTrials.gov