Clinical trial NCT02145195: The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
Official title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Children
Supplements
Cardiometabolic markers
Immune defense
Bone turnover
Muscle strength
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University College Cork
name: University of Surrey
First posted: 2014-05-22
Enrollment: 130
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.

Detailed description: The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* 4-8 years at the start of the intervention
* healthy
* of white, Danish/European origin
* children must be Danish-speaking
* parents must read and speak Danish
* not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)

Exclusion Criteria:

* diseases that may interfere with vitamin D or calcium metabolism
* intake of medication known to affect vitamin D or calcium metabolism
* use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
* concomitant participation in other studies involving dietary supplements or blood sampling
* serum calcium \> 2.7 mmol/L at baseline

Primary outcomes:
measure: Change in vitamin D status
timeFrame: Baseline and 20 weeks
Secondary outcomes:
measure: Change in anthropometric measurements
timeFrame: Baseline and 20 weeks
measure: Change in body composition
timeFrame: Baseline and 20 weeks
measure: Serum calcium
timeFrame: Baseline and 20 weeks
Other outcomes:
measure: Change in cardio-metabolic markers
timeFrame: Baseline and 20 weeks
measure: Change in markers of immune defense
timeFrame: Baseline and 20 weeks
measure: Change in muscle strength
timeFrame: Baseline and 20 weeks
measure: Dietary intake of vitamin D and calcium
timeFrame: Baseline and 20 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
state: Frederiksberg
Study officials:
affiliation: Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen
name: Christian Mølgaard, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.
citation: Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.
citation: Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.
citation: Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.