Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02145195
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : March 25, 2015
Sponsor:
Collaborators:
University College Cork
University of Surrey
Information provided by (Responsible Party):
Christian Mølgaard, 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Vitamin D3 (cholecalciferol) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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.



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


Secondary Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145195


Locations
Layout table for location information
Denmark
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
University College Cork
University of Surrey
Investigators
Layout table for investigator information
Principal Investigator: Christian Mølgaard, PhD, MD Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christian Mølgaard, MD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02145195     History of Changes
Other Study ID Numbers: D214
European Commission ( Other Grant/Funding Number: Contract no. 613977 )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Christian Mølgaard, University of Copenhagen:
Vitamin D
Children
Supplements
Cardiometabolic markers
Immune defense
Bone turnover
Muscle strength
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents