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

Vitamin D Deficiency Clinical Trial

— ODIN Junior  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145195
• Other study ID #: D214
• Secondary ID: European Commiss
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: March 24, 2015
• Start date: June 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3 (cholecalciferol)

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	University College Cork, University of Surrey

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in cardio-metabolic markers	Blood pressure, insulin, cholesterols etc.	Baseline and 20 weeks	No
Other	Change in markers of immune defense	Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides.	Baseline and 20 weeks	No
Other	Change in muscle strength	Maximum hand grip strength.	Baseline and 20 weeks	No
Other	Dietary intake of vitamin D and calcium	Assessed by questionnaire	Baseline and 20 weeks	No
Primary	Change in vitamin D status	Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]	Baseline and 20 weeks	No
Secondary	Change in anthropometric measurements	Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.	Baseline and 20 weeks	No
Secondary	Change in body composition	Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).	Baseline and 20 weeks	No
Secondary	Serum calcium	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	Yes