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

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Vitamin D3 (cholecalciferol)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Children, Supplements, Cardiometabolic markers, Immune defense, Bone turnover, Muscle strength

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vitamin D (10 microgram/day)

Vitamin D (20 microgram/day)

Placebo control

Arm Description

Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.

Tablets with 0 microgram vitamin D daily for 20 weeks.

Outcomes

Primary Outcome Measures

Change in vitamin D status
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]

Secondary Outcome Measures

Change in anthropometric measurements
Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
Change in body composition
Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).
Serum calcium
Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit.

Full Information

First Posted
May 20, 2014
Last Updated
March 24, 2015
Sponsor
University of Copenhagen
Collaborators
University College Cork, University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT02145195
Brief Title
The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children
Acronym
ODIN Junior
Official Title
Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
University College Cork, University of Surrey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
Vitamin D, Children, Supplements, Cardiometabolic markers, Immune defense, Bone turnover, Muscle strength

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D (10 microgram/day)
Arm Type
Experimental
Arm Description
Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
Arm Title
Vitamin D (20 microgram/day)
Arm Type
Experimental
Arm Description
Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
Tablets with 0 microgram vitamin D daily for 20 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (cholecalciferol)
Primary Outcome Measure Information:
Title
Change in vitamin D status
Description
Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
Time Frame
Baseline and 20 weeks
Secondary Outcome Measure Information:
Title
Change in anthropometric measurements
Description
Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
Time Frame
Baseline and 20 weeks
Title
Change in body composition
Description
Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2).
Time Frame
Baseline and 20 weeks
Title
Serum calcium
Description
Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit.
Time Frame
Baseline and 20 weeks
Other Pre-specified Outcome Measures:
Title
Change in cardio-metabolic markers
Description
Blood pressure, insulin, cholesterols etc.
Time Frame
Baseline and 20 weeks
Title
Change in markers of immune defense
Description
Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides.
Time Frame
Baseline and 20 weeks
Title
Change in muscle strength
Description
Maximum hand grip strength.
Time Frame
Baseline and 20 weeks
Title
Dietary intake of vitamin D and calcium
Description
Assessed by questionnaire
Time Frame
Baseline and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Mølgaard, PhD, MD
Organizational Affiliation
Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30189911
Citation
Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Sun behaviour and physical activity associated with autumn vitamin D status in 4-8-year-old Danish children. Public Health Nutr. 2018 Dec;21(17):3158-3167. doi: 10.1017/S1368980018002094. Epub 2018 Sep 7.
Results Reference
derived
PubMed Identifier
29917069
Citation
Hauger H, Molgaard C, Mortensen C, Ritz C, Frokiaer H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55 degrees N Has No Effect on Markers of Cardiometabolic Risk in Healthy Children Aged 4-8 Years. J Nutr. 2018 Aug 1;148(8):1261-1268. doi: 10.1093/jn/nxy080.
Results Reference
derived
PubMed Identifier
29450728
Citation
Mortensen C, Molgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D3 supplementation does not increase muscle strength, but modulates the IGF-axis in young children. Eur J Nutr. 2019 Apr;58(3):1183-1192. doi: 10.1007/s00394-018-1637-x. Epub 2018 Feb 15.
Results Reference
derived
PubMed Identifier
27733403
Citation
Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy A, Dowling K, Cashman KD, Kiely M, Molgaard C. Estimation of the dietary requirement for vitamin D in white children aged 4-8 y: a randomized, controlled, dose-response trial. Am J Clin Nutr. 2016 Nov;104(5):1310-1317. doi: 10.3945/ajcn.116.136697. Epub 2016 Oct 12.
Results Reference
derived

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

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