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Completed

NCT Number: NCT02145195

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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D3 (cholecalciferol)

Dietary Supplement

Primary outcomes

  1. Change in vitamin D status

    Time frame: Baseline and 20 weeks

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

Secondary outcomes

  1. Change in anthropometric measurements

    Time frame: Baseline and 20 weeks

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

  2. 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).

  3. 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.

Other outcomes

  1. Change in cardio-metabolic markers

    Time frame: Baseline and 20 weeks

    Blood pressure, insulin, cholesterols etc.

  2. 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.

  3. Change in muscle strength

    Time frame: Baseline and 20 weeks

    Maximum hand grip strength.

  4. Dietary intake of vitamin D and calcium

    Time frame: Baseline and 20 weeks

    Assessed by questionnaire

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • University College Cork
  • University of Surrey

Registry information

Official study title

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

Acronym: ODIN Junior

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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