Bone HealthD-proNCT03956732
Effects of Milk Protein and Vitamin D on Children's Growth and Health
A study testing Milk Protein (high), Vitamin D and Milk Protein (medium) in people with Bone Health and Muscle Function, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Health, Muscle Function, Cardiometabolic Health
- What is being tested?
- Milk Protein (high), Vitamin D and Milk Protein (medium)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Jun 2019to 3 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg
About this study
Official title: Effects of Milk Protein and Vitamin D on Children's Growth and Health (D-pro)
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.
Read the detailed description
The D-pro study investigates the effects of high or medium intakes of milk protein, and vitamin D supplements or placebo, in healthy 6-8 year-old Danish children. The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to receive yoghurt products with either high or medium protein content (300g/day, 6 days/week) and to receive tablets with either vitamin D (20 μg/day) or placebo for 24 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.
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.
- Being tested
- Milk Protein (high), Vitamin D, Milk Protein (medium)
- Keywords
- Child Nutrition, Dietary recommendations, Milk protein, Vitamin D, Bone mineral density, Muscle strength, Immune defence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Vitamin DDietary supplement
One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
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.
| Study group | Role | What they receive |
|---|---|---|
| High protein yoghurt and vitamin D supplement | Experimental | Subjects will receive high protein yoghurt and vitamin D tablets. Receives: 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. Receives: Dietary Supplement: Milk Protein (high) |
| Medium protein yoghurt and vitamin D supplement | Experimental | Subjects will receive medium protein yoghurt and vitamin D tablets. Receives: 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. Receives: Dietary Supplement: Milk Protein (medium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density (BMD)
Measured by dual energy x-ray absorptiometry (DXA)
Measured: 24 weeks
Secondary outcomes (26)
Bone Mineral Content (BMC)
by DXA
Measured: 24 weeks
Fat mass index
by DXA
Measured: 24 weeks
Fat free mass index
by DXA
Measured: 24 weeks
Bone area
by DXA
Measured: 24 weeks
Height
by stadiometer
Measured: 24 weeks
Waist circumference
Measured: 24 weeks
Insulin-like Growth Factor 1 (IGF-1)
by fasting blood sample
Measured: 24 weeks
Insulin-like growth factor-binding protein 3 (IGFBP-3)
by fasting blood sample
Measured: 24 weeks
Serum calcium
by fasting blood sample
Measured: 24 weeks
Osteocalcin
by fasting blood sample
Measured: 24 weeks
Parathyroid hormone (PTH)
by fasting blood sample
Measured: 24 weeks
Bone-specific alkaline phosphatase
by fasting blood sample
Measured: 24 weeks
C-terminal telopeptide of type 1 collagen in serum (s-CTX)
by fasting blood sample
Measured: 24 weeks
Maximal leg press strength
Measured by isometric leg press
Measured: 24 weeks
Maximal jumping height
Measured by squat jump with linear encoder
Measured: 24 weeks
Maximal jumping length
Measured by standing long jump
Measured: 24 weeks
Maximal grip strength
Measured by hand grip dynamometer
Measured: 24 weeks
Muscle endurance
Measured by 30 sec. sit-to-stand
Measured: 24 weeks
Blood pressure
Measured: 24 weeks
Hemoglobin A1c (HbA1c)
by fasting blood sample
Measured: 24 weeks
Glucose
by fasting blood sample
Measured: 24 weeks
Insulin
by fasting blood sample
Measured: 24 weeks
Total cholesterol
by fasting blood sample
Measured: 24 weeks
High density lipoprotein cholesterol (HDL cholesterol)
by fasting blood sample
Measured: 24 weeks
Low density lipoprotein cholesterol (LDL cholesterol)
by fasting blood sample
Measured: 24 weeks
Triacylglycerol (TG)
by fasting blood sample
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start20 Jun 2019
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Arla Foods
- Responsible party
- Principal investigator, Camilla Trab Damsgaard, University of Copenhagen
- Investigators
- Camilla T Damsgaard, Assoc Prof, Principal investigator, University of CopenhagenChristian Mølgaard, Prof, Study chair, University of CopenhagenMette Hansen, Assoc Prof, Study chair, Institute of Public Health, Aarhus University, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956732
- Sponsor's protocol ID
- D224
- Acronym
- D-pro
- Status last verified
- Apr 2020
- First submitted
- 16 May 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40310565Thams 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.
PubMed 35643873Thams 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.
PubMed 35015806Stounbjerg 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.
PubMed 34581765
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Milk Protein and Vitamin D on Children's Growth and Health (D-pro)
- ClinicalTrials.gov ID
- NCT03956732
- Acronym / sponsor ID
- D-pro / D224
- Keywords
- Child Nutrition, Dietary recommendations, Milk protein, Vitamin D, Bone mineral density, Muscle strength, Immune defence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Aarhus, Arla Foods
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The D-pro study investigates the effects of high or medium intakes of milk protein, and vitamin D supplements or placebo, in healthy 6-8 year-old Danish children. The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to receive yoghurt products with either high or medium protein content (300g/day, 6 days/week) and to receive tablets with either vitamin D (20 μg/day) or placebo for 24 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High protein yoghurt and vitamin D supplement | Experimental | Dietary Supplement: Milk Protein (high), Dietary Supplement: Vitamin DSubjects will receive high protein yoghurt and vitamin D tablets. |
| High protein yoghurt and placebo supplement | Experimental | Dietary Supplement: Milk Protein (high)Subjects will receive high protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D. |
| Medium protein yoghurt and vitamin D supplement | Experimental | Dietary Supplement: Vitamin D, Dietary Supplement: Milk Protein (medium)Subjects will receive medium protein yoghurt and vitamin D tablets. |
| Medium protein yoghurt and placebo supplement | Placebo comparator | Dietary Supplement: Milk Protein (medium)Subjects will receive medium protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | High protein yoghurt and placebo supplement, High protein yoghurt and vitamin D supplement |
| Vitamin DOne daily tablet containing 20 μg of vitamin D3, cholecalciferol. | Dietary supplement | High protein yoghurt and vitamin D supplement, Medium protein yoghurt and vitamin D supplement |
| 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. | Dietary supplement | Medium protein yoghurt and placebo supplement, Medium protein yoghurt and vitamin D supplement |
Primary outcome
Bone Mineral Density (BMD)
Time frame: 24 weeks
Measured by dual energy x-ray absorptiometry (DXA)
26 secondary outcomes
Bone Mineral Content (BMC)
Time frame: 24 weeks
Fat mass index
Time frame: 24 weeks
Fat free mass index
Time frame: 24 weeks
Bone area
Time frame: 24 weeks
Height
Time frame: 24 weeks
Waist circumference
Time frame: 24 weeks
Insulin-like Growth Factor 1 (IGF-1)
Time frame: 24 weeks
Insulin-like growth factor-binding protein 3 (IGFBP-3)
Time frame: 24 weeks
Serum calcium
Time frame: 24 weeks
Osteocalcin
Time frame: 24 weeks
Parathyroid hormone (PTH)
Time frame: 24 weeks
Bone-specific alkaline phosphatase
Time frame: 24 weeks
C-terminal telopeptide of type 1 collagen in serum (s-CTX)
Time frame: 24 weeks
Maximal leg press strength
Time frame: 24 weeks
Maximal jumping height
Time frame: 24 weeks
Maximal jumping length
Time frame: 24 weeks
Maximal grip strength
Time frame: 24 weeks
Muscle endurance
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Hemoglobin A1c (HbA1c)
Time frame: 24 weeks
Glucose
Time frame: 24 weeks
Insulin
Time frame: 24 weeks
Total cholesterol
Time frame: 24 weeks
High density lipoprotein cholesterol (HDL cholesterol)
Time frame: 24 weeks
Low density lipoprotein cholesterol (LDL cholesterol)
Time frame: 24 weeks
Triacylglycerol (TG)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 40310565Clerico 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.
- Derived from this study: PubMed 35643873Thams 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.
- Derived from this study: PubMed 35015806Thams 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.
- Derived from this study: PubMed 34581765Stounbjerg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla T Damsgaard, Assoc Prof principal investigator
University of Copenhagen
Christian Mølgaard, Prof study chair
University of Copenhagen
Mette Hansen, Assoc Prof study chair
Institute of Public Health, Aarhus University, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Protein (high), Vitamin D and Milk Protein (medium) in people with Bone Health and Muscle Function, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Mineral Density (BMD) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956732, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.