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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dietary Requirement for Vitamin D in Adolescents Aged 14-18 Years

NCT02150122

Serum 25-hydroxyvitamin D Concentrations (25OHD)

COMPLETED NA

Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]

NCT01537809

Vitamin D Deficiency

COMPLETED NA

The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls

NCT00267540

Vitamin D Deficiency

COMPLETED NA

An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health

NCT03892395

Bone Health

COMPLETED NA

Vitamin D and Hand Grip Strength at 5 Years in Odense Child Cohort

NCT03381378

Hypovitaminosis D Hand Grasp Children

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D (10 microgram/day)

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

Group Type EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Vitamin D (20 microgram/day)

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

Group Type EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Placebo control

Tablets with 0 microgram vitamin D daily for 20 weeks.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D3 (cholecalciferol)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes