Viewing Study NCT02145195


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Study NCT ID: NCT02145195
Status: COMPLETED
Last Update Posted: 2015-03-25
First Post: 2014-05-20
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
Sponsor: University of Copenhagen
Organization:

Study Overview

Official Title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ODIN Junior
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
European Commission OTHER_GRANT Contract no. 613977 View