Effects of Milk Protein and Vitamin D on Children's Growth and Health

NCT03956732 | Completed DMC

• 1 other identifier: D224
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of D-pro is to investigate the combined and separate effects of milk protein and vitamin D on bone health, growth, muscle function, body composition and cardiometabolic health in 6-8-year-old children.

Conditions

Bone Health; Muscle Function; Cardiometabolic Health; Appetite Regulation

Keywords

Child Nutrition; Dietary recommendations; Milk protein; Vitamin D; Bone mineral density; Muscle strength; Immune defence

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD)

  Measured by dual energy x-ray absorptiometry (DXA)

  24 weeks

Secondary Outcomes (26)

• Bone Mineral Content (BMC)

  24 weeks

• Fat mass index

  24 weeks

• Fat free mass index

  24 weeks

• Bone area

  24 weeks

• Height

  24 weeks

Other Outcomes (18)

• Physical activity

  24 weeks

• C-peptide

  24 weeks

• Vitamin D binding protein

  24 weeks

Study Arms (4)

High protein yoghurt and vitamin D supplement

EXPERIMENTAL

Subjects will receive high protein yoghurt and vitamin D tablets.

Dietary Supplement: Milk Protein (high); Dietary Supplement: Vitamin D

High protein yoghurt and placebo supplement

EXPERIMENTAL

Subjects will receive high protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.

Dietary Supplement: Milk Protein (high)

Medium protein yoghurt and vitamin D supplement

EXPERIMENTAL

Subjects will receive medium protein yoghurt and vitamin D tablets.

Dietary Supplement: Vitamin D; Dietary Supplement: Milk Protein (medium)

Medium protein yoghurt and placebo supplement

PLACEBO COMPARATOR

Subjects will receive medium protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.

Dietary Supplement: Milk Protein (medium)

Interventions

Milk Protein (high) DIETARY_SUPPLEMENT

High protein yoghurt which contains approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.

High protein yoghurt and placebo supplement; High protein yoghurt and vitamin D supplement

Vitamin D DIETARY_SUPPLEMENT

One daily tablet containing 20 μg of vitamin D3, cholecalciferol.

High protein yoghurt and vitamin D supplement; Medium protein yoghurt and vitamin D supplement

Milk Protein (medium) DIETARY_SUPPLEMENT

Ordinary yoghurt containing approx. 3.3 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.

Medium protein yoghurt and placebo supplement; Medium protein yoghurt and vitamin D supplement

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children must:
• Be 6-8 years of age at the start of the intervention
• Be healthy
• Have a frequent intake of milk and yoghurt products, corresponding to at least ¼ liter a day
• Like yoghurt and high protein yoghurt ("skyr")
• Be of white, Danish or European origin
• Moreover:
• The family must not be planning a winter vacation south of a latitude of 50° North
• The child must speak and understand Danish in order to understand the study procedures
• At least one parent must read, speak and write Danish

You may not qualify if:

• Known or suspected allergy or intolerance to milk or milk components
• Chronic illness or disease that may affect study outcomes
• Chronic intake of medicine that may affect study outcomes
• Use of vitamin D-containing supplements \>3 days/week the 2 last months and use of any vitamin D-containing supplements the last 1 month before intervention start
• Concomitant participation in other studies involving dietary supplements or blood sampling
• Living in a household with another participating child

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Aarhus: collaborator
• Arla Foods: collaborator
• Arla Foods Ingredients: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg, Denmark

Location

Related Publications (4)

• Clerico JW, Thams L, Stounbjerg NG, Hauger H, Damsgaard CT, Molgaard C. Effects of vitamin D supplementation on acute respiratory tract infections in 6-8-year-old children: a randomized clinical trial. Eur J Nutr. 2025 May 1;64(4):170. doi: 10.1007/s00394-025-03674-1.

  PMID: 40310565 DERIVED

• Thams L, Hvid LG, Stounbjerg NG, Brond JC, Molgaard C, Damsgaard CT, Hansen M. Vitamin D supplementation and increased dairy protein intake do not affect muscle strength or physical function in healthy 6-8-year-old children: the D-pro randomized trial. Eur J Nutr. 2022 Oct;61(7):3613-3623. doi: 10.1007/s00394-022-02912-0. Epub 2022 May 28.

  PMID: 35643873 DERIVED

• Thams L, Stounbjerg NG, Hvid LG, Molgaard C, Hansen M, Damsgaard CT. Effects of high dairy protein intake and vitamin D supplementation on body composition and cardiometabolic markers in 6-8-y-old children-the D-pro trial. Am J Clin Nutr. 2022 Apr 1;115(4):1080-1091. doi: 10.1093/ajcn/nqab424.

  PMID: 35015806 DERIVED

• Stounbjerg NG, Thams L, Hansen M, Larnkjaer A, Clerico JW, Cashman KD, Molgaard C, Damsgaard CT. Effects of vitamin D and high dairy protein intake on bone mineralization and linear growth in 6- to 8-year-old children: the D-pro randomized trial. Am J Clin Nutr. 2021 Dec 1;114(6):1971-1985. doi: 10.1093/ajcn/nqab286.

  PMID: 34581765 DERIVED

MeSH Terms

Interventions

Milk Proteins; Vitamin D; Culture Media

Intervention Hierarchy (Ancestors)

Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Milk; Dairy Products; Food and Beverages; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• Camilla T Damsgaard, Assoc Prof

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Christian Mølgaard, Prof

  University of Copenhagen

  STUDY CHAIR

• Mette Hansen, Assoc Prof

  Institute of Public Health, Aarhus University, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: D-pro will be double-blinded in respect to D vitamin supplementation or placebo, whereas the allocation of yoghurt with high versus medium milk protein content will not be blinded.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 21, 2019
• Study Start: June 20, 2019
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

DK (1)