Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Children, Supplements, Cardiometabolic markers, Immune defense, Bone turnover, Muscle strength
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3 (cholecalciferol)
Sponsors
University College Cork
University of Surrey
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vitamin D status | Baseline and 20 weeks | Serum concentrations of total 25-hydroxyvitamin D \[25(OH)D\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anthropometric measurements | Baseline and 20 weeks | Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores. |
| Change in body composition | Baseline and 20 weeks | Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2). |
| Serum calcium | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in cardio-metabolic markers | Baseline and 20 weeks | Blood pressure, insulin, cholesterols etc. |
| Change in markers of immune defense | Baseline and 20 weeks | Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides. |
| Change in muscle strength | Baseline and 20 weeks | Maximum hand grip strength. |
| Dietary intake of vitamin D and calcium | Baseline and 20 weeks | Assessed by questionnaire |
Countries
Denmark
Outcome results
None listed