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

March 24, 2015 updated by: Christian Mølgaard, University of Copenhagen

Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 1958
        • Department of Nutrition, Exercise and Sports

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D (10 microgram/day)
Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
Dietary supplement: Vitamin D3 (cholecalciferol)
Experimental: Vitamin D (20 microgram/day)
Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
Dietary supplement: Vitamin D3 (cholecalciferol)
Placebo Comparator: Placebo control
Tablets with 0 microgram vitamin D daily for 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vitamin D status
Time Frame: Baseline and 20 weeks
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
Baseline and 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anthropometric measurements
Time Frame: Baseline and 20 weeks
Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
Baseline and 20 weeks
Change in body composition
Time Frame: Baseline and 20 weeks
Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).
Baseline and 20 weeks
Serum calcium
Time Frame: 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.
Baseline and 20 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardio-metabolic markers
Time Frame: Baseline and 20 weeks
Blood pressure, insulin, cholesterols etc.
Baseline and 20 weeks
Change in markers of immune defense
Time Frame: Baseline and 20 weeks
Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides.
Baseline and 20 weeks
Change in muscle strength
Time Frame: Baseline and 20 weeks
Maximum hand grip strength.
Baseline and 20 weeks
Dietary intake of vitamin D and calcium
Time Frame: Baseline and 20 weeks
Assessed by questionnaire
Baseline and 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

University College Cork
University of Surrey

Investigators

  • Principal Investigator: Christian Mølgaard, PhD, MD, Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D214
  • European Commission (Other Grant/Funding Number: Contract no. 613977)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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