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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D3 (cholecalciferol)

• Registration Number: NCT02145195
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-22
• Study Start: 2014-06
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D (10 microgram/day)	Vitamin D3 (cholecalciferol)	Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
Vitamin D (20 microgram/day)	Vitamin D3 (cholecalciferol)	Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Primary Outcome Measures

Name	Time	Method
Change in vitamin D status	Baseline and 20 weeks	Serum concentrations of total 25-hydroxyvitamin D \[25(OH)D\]

Secondary Outcome Measures

Name	Time	Method
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).
Change in anthropometric measurements	Baseline and 20 weeks	Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
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.

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports; 🇩🇰 Copenhagen, Frederiksberg, Denmark