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

NCT02387892 | Completed

• 1 other identifier: HW-14-01-P2
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Vitamin D serum concentration

  How much vitamin D intake from food is required to maintain vitamin D status consistent with 50 nmol/L of serum 25(OH)D in all children from the beginning of the UVB-void period (beginning of October) to the end of the winter period (end of April).

  6 month

Secondary Outcomes (4)

• Bone Mineral Density

  6 month

• Bone Mineral Density

  6 month

• Body Composition

  6 month

• Body Compositon

  6 month

Study Arms (2)

Control

PLACEBO COMPARATOR

Cheese \& yogurt

Dietary Supplement: Cheese & yogurt

Treatment

EXPERIMENTAL

Cheese \& yogurt + Vitamin D

Dietary Supplement: Cheese & yogurt + Vitamin D

Interventions

Cheese & yogurt + Vitamin D DIETARY_SUPPLEMENT

cheese \& yogurt with added 420 IU cholecalciferol

Also known as: dairy products + cholecalciferol

Treatment

Cheese & yogurt DIETARY_SUPPLEMENT

Cheese \& yogurt without added vitamin D

Also known as: dairy products

Control

Eligibility Criteria

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

You may qualify if:

• Children 2 through 8 years of age;
• Healthy body weight for age.

You may not qualify if:

• Regular use of vitamin D supplements;
• Lactose intolerant;
• Don't drink milk or eat cheese or yogurt;
• Prior treatment for biochemically confirmed vitamin D deficiency;
• Known or suspected medical conditions associated with bone and vitamin D including rickets, osteomalacia, liver disease, renal disease, immobilization (complete or partial), fractures, and disorders of the parathyroid gland;
• Known or suspected chronic illness of childhood, such as asthma, cancer, Crohn's disease, nephrotic syndrome, rheumatic conditions, and diabetes, etc;
• Use in the past 3 months of medications known to affect bone and/or mineral ion metabolism including oral/systemic/inhaled glucocorticoids, phosphate therapy or vitamin D analogues. Bisphosphonates are also included in this category;
• however, because of their long-half lives and persistence in bone tissue, any prior use of bisphosphonate therapy precludes enrolment;
• Conditions in which the procurement of 8 ml of blood would compromise the health of the patient (i.e. patients with severe anemia).

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)

• Brett NR, Parks CA, Lavery P, Agellon S, Vanstone CA, Kaufmann M, Jones G, Maguire JL, Rauch F, Weiler HA. Vitamin D status and functional health outcomes in children aged 2-8 y: a 6-mo vitamin D randomized controlled trial. Am J Clin Nutr. 2018 Mar 1;107(3):355-364. doi: 10.1093/ajcn/nqx062.

  PMID: 29566192 DERIVED

MeSH Terms

Interventions

Cheese; Yogurt; Vitamin D; Dairy Products; Cholecalciferol

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Food; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 13, 2015
• Study Start: October 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)