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

University of Copenhagen130 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

130

Conditions

Vitamin D Deficiency

Interventions

Vitamin D3 (cholecalciferol)DIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, Denmark

Outcomes

Primary Outcomes

Change in vitamin D status

Serum concentrations of total 25-hydroxyvitamin D \[25(OH)D\]

Time frame: Baseline and 20 weeks

Secondary Outcomes

Change in anthropometric measurements

Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.

Time frame: Baseline and 20 weeks

Change in body composition

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

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

Data from ClinicalTrials.gov

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