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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)

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

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

NCT ID

NCT02145195

First Posted

May 20, 2014

Last Updated

March 24, 2015

Sponsor

University of Copenhagen

Collaborators

University College Cork, University of Surrey

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

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

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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