Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958, Denmark
NCT Number: NCT02145195
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.
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Notify Me4 year–8 year
All sexes
Interventional
Not applicable
Copenhagen, Frederiksberg, 1958, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and 20 weeks
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
Time frame: Baseline and 20 weeks
Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
Time frame: Baseline and 20 weeks
Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).
Time frame: Baseline and 20 weeks
Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit.
Time frame: Baseline and 20 weeks
Blood pressure, insulin, cholesterols etc.
Time frame: Baseline and 20 weeks
Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides.
Time frame: Baseline and 20 weeks
Maximum hand grip strength.
Time frame: Baseline and 20 weeks
Assessed by questionnaire
University of Copenhagen
Other
Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Acronym: ODIN Junior
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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