The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children (ODIN Junior)

University of Copenhagen

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: Vitamin D3 (cholecalciferol)

Study type: Interventional

Funder types: Other

Identifiers

NCT02145195

European Commission

D214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 3 patient groups, including a placebo group

Vitamin D (10 microgram/day)

Experimental group

Description:

Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)

Vitamin D (20 microgram/day)

Experimental group

Description:

Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol)

Placebo control

Placebo Comparator group

Description:

Tablets with 0 microgram vitamin D daily for 20 weeks.