Effects of Milk Protein and Vitamin D on Children's Growth and Health
NCT ID: NCT03956732
Last Updated: 2020-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-06-20
2020-04-03
Brief Summary
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Detailed Description
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The primary outcome will be bone mineral density (BMD). The investigators will also measure effects on children's muscle function, cardiometabolic health, body composition, growth and growth factors, nutrient status, immune defence and risk of acute respiratory tract infections, as well as appetite hormones. The investigators will also assess potential sex-specific effects and the potential modifying effect of genotype.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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High protein yoghurt and vitamin D supplement
Subjects will receive high protein yoghurt and vitamin D tablets.
Milk Protein (high)
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.
Vitamin D
One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
High protein yoghurt and placebo supplement
Subjects will receive high protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.
Milk Protein (high)
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.
Medium protein yoghurt and vitamin D supplement
Subjects will receive medium protein yoghurt and vitamin D tablets.
Vitamin D
One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
Milk Protein (medium)
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
Subjects will receive medium protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.
Milk Protein (medium)
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.
Interventions
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Milk Protein (high)
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.
Vitamin D
One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
Milk Protein (medium)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
6 Years
8 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Arla Foods
INDUSTRY
Arla Foods Ingredients
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Camilla Trab Damsgaard
Associate Professor
Principal Investigators
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Camilla T Damsgaard, Assoc Prof
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition, Exercise and sports, University of Copenhagen
Christian Mølgaard, Prof
Role: STUDY_CHAIR
Department of Nutrition, Exercise and sports, University of Copenhagen
Mette Hansen, Assoc Prof
Role: STUDY_CHAIR
Institute of Public Health, Aarhus University, Denmark
Locations
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Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg, , Denmark
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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D224
Identifier Type: -
Identifier Source: org_study_id
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