Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT03956732
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2019-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Milk Protein and Vitamin D on Children's Growth and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D003470', 'term': 'Culture Media'}], 'ancestors': [{'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity', 'timeFrame': '24 weeks', 'description': 'by accelerometry'}, {'measure': 'C-peptide', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Vitamin D binding protein', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Serum 25(OH) vitamin D', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': '1,25(OH)2vitamin D', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Urea', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Interleukin-1β (IL-1β)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Tumor necrosis factor a (TNF-a)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Leptin', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Adiponectin', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'High sensitivity C-reactive protein (hsCRP)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Immune cell counts', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Immuno-active peptides in nasal fluid', 'timeFrame': '24 weeks', 'description': 'by nasal fluid sample'}, {'measure': 'Immuno-active peptides in blood', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Respiratory tract infections', 'timeFrame': '24 weeks', 'description': 'by questionnaires'}, {'measure': 'Dietary intake', 'timeFrame': '24 weeks', 'description': 'By 4-day dietary record'}, {'measure': 'Vitamin D and calcium intake', 'timeFrame': '24 weeks', 'description': 'By food frequency questionnaire'}], 'primaryOutcomes': [{'measure': 'Bone Mineral Density (BMD)', 'timeFrame': '24 weeks', 'description': 'Measured by dual energy x-ray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Bone Mineral Content (BMC)', 'timeFrame': '24 weeks', 'description': 'by DXA'}, {'measure': 'Fat mass index', 'timeFrame': '24 weeks', 'description': 'by DXA'}, {'measure': 'Fat free mass index', 'timeFrame': '24 weeks', 'description': 'by DXA'}, {'measure': 'Bone area', 'timeFrame': '24 weeks', 'description': 'by DXA'}, {'measure': 'Height', 'timeFrame': '24 weeks', 'description': 'by stadiometer'}, {'measure': 'Waist circumference', 'timeFrame': '24 weeks'}, {'measure': 'Insulin-like Growth Factor 1 (IGF-1)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Insulin-like growth factor-binding protein 3 (IGFBP-3)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Serum calcium', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Osteocalcin', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Parathyroid hormone (PTH)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Bone-specific alkaline phosphatase', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'C-terminal telopeptide of type 1 collagen in serum (s-CTX)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Maximal leg press strength', 'timeFrame': '24 weeks', 'description': 'Measured by isometric leg press'}, {'measure': 'Maximal jumping height', 'timeFrame': '24 weeks', 'description': 'Measured by squat jump with linear encoder'}, {'measure': 'Maximal jumping length', 'timeFrame': '24 weeks', 'description': 'Measured by standing long jump'}, {'measure': 'Maximal grip strength', 'timeFrame': '24 weeks', 'description': 'Measured by hand grip dynamometer'}, {'measure': 'Muscle endurance', 'timeFrame': '24 weeks', 'description': 'Measured by 30 sec. sit-to-stand'}, {'measure': 'Blood pressure', 'timeFrame': '24 weeks'}, {'measure': 'Hemoglobin A1c (HbA1c)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Glucose', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Insulin', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Total cholesterol', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'High density lipoprotein cholesterol (HDL cholesterol)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Low density lipoprotein cholesterol (LDL cholesterol)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}, {'measure': 'Triacylglycerol (TG)', 'timeFrame': '24 weeks', 'description': 'by fasting blood sample'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child Nutrition', 'Dietary recommendations', 'Milk protein', 'Vitamin D', 'Bone mineral density', 'Muscle strength', 'Immune defence'], 'conditions': ['Bone Health', 'Muscle Function', 'Cardiometabolic Health', 'Appetite Regulation']}, 'referencesModule': {'references': [{'pmid': '40310565', 'type': 'DERIVED', 'citation': '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': '35643873', 'type': 'DERIVED', 'citation': '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': '35015806', 'type': 'DERIVED', 'citation': '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': '34581765', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren must:\n\n* Be 6-8 years of age at the start of the intervention\n* Be healthy\n* Have a frequent intake of milk and yoghurt products, corresponding to at least ¼ liter a day\n* Like yoghurt and high protein yoghurt ("skyr")\n* Be of white, Danish or European origin\n\nMoreover:\n\n* The family must not be planning a winter vacation south of a latitude of 50° North\n* The child must speak and understand Danish in order to understand the study procedures\n* At least one parent must read, speak and write Danish\n\nExclusion Criteria:\n\n* Known or suspected allergy or intolerance to milk or milk components\n* Chronic illness or disease that may affect study outcomes\n* Chronic intake of medicine that may affect study outcomes\n* 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\n* Concomitant participation in other studies involving dietary supplements or blood sampling\n* Living in a household with another participating child'}, 'identificationModule': {'nctId': 'NCT03956732', 'acronym': 'D-pro', 'briefTitle': "Effects of Milk Protein and Vitamin D on Children's Growth and Health", 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': "Effects of Milk Protein and Vitamin D on Children's Growth and Health (D-pro)", 'orgStudyIdInfo': {'id': 'D224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High protein yoghurt and vitamin D supplement', 'description': 'Subjects will receive high protein yoghurt and vitamin D tablets.', 'interventionNames': ['Dietary Supplement: Milk Protein (high)', 'Dietary Supplement: Vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'High protein yoghurt and placebo supplement', 'description': 'Subjects will receive high protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.', 'interventionNames': ['Dietary Supplement: Milk Protein (high)']}, {'type': 'EXPERIMENTAL', 'label': 'Medium protein yoghurt and vitamin D supplement', 'description': 'Subjects will receive medium protein yoghurt and vitamin D tablets.', 'interventionNames': ['Dietary Supplement: Vitamin D', 'Dietary Supplement: Milk Protein (medium)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Medium protein yoghurt and placebo supplement', 'description': 'Subjects will receive medium protein yoghurt and placebo tablets of identical appearance and taste but without vitamin D.', 'interventionNames': ['Dietary Supplement: Milk Protein (medium)']}], 'interventions': [{'name': 'Milk Protein (high)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['High protein yoghurt and placebo supplement', 'High protein yoghurt and vitamin D supplement']}, {'name': 'Vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One daily tablet containing 20 μg of vitamin D3, cholecalciferol.', 'armGroupLabels': ['High protein yoghurt and vitamin D supplement', 'Medium protein yoghurt and vitamin D supplement']}, {'name': 'Milk Protein (medium)', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Medium protein yoghurt and placebo supplement', 'Medium protein yoghurt and vitamin D supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Nutrition, Exercise and Sports, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Camilla T Damsgaard, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, Exercise and sports, University of Copenhagen'}, {'name': 'Christian Mølgaard, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Nutrition, Exercise and sports, University of Copenhagen'}, {'name': 'Mette Hansen, Assoc Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Public Health, Aarhus University, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Arla Foods', 'class': 'INDUSTRY'}, {'name': 'Arla Foods Ingredients', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Camilla Trab Damsgaard', 'investigatorAffiliation': 'University of Copenhagen'}}}}