The Effect of Vitamin D Supplements on Vitamin D Status, Cardiometabolic Health and Immune Defense in Danish Children (ODIN Junior)
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ClinicalTrials.gov Identifier: NCT02145195 |
Recruitment Status :
Completed
First Posted : May 22, 2014
Last Update Posted : March 25, 2015
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Condition or disease | Intervention/treatment | Phase |
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Vitamin D Deficiency | Dietary Supplement: Vitamin D3 (cholecalciferol) | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Vitamin D (10 microgram/day)
Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
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Dietary Supplement: Vitamin D3 (cholecalciferol) |
Experimental: Vitamin D (20 microgram/day)
Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.
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Dietary Supplement: Vitamin D3 (cholecalciferol) |
Placebo Comparator: Placebo control
Tablets with 0 microgram vitamin D daily for 20 weeks.
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- Change in vitamin D status [ Time Frame: Baseline and 20 weeks ]Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]
- Change in anthropometric measurements [ Time Frame: Baseline and 20 weeks ]Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
- 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).
- 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.
- Change in cardio-metabolic markers [ Time Frame: Baseline and 20 weeks ]Blood pressure, insulin, cholesterols etc.
- 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.
- Change in muscle strength [ Time Frame: Baseline and 20 weeks ]Maximum hand grip strength.
- Dietary intake of vitamin D and calcium [ Time Frame: Baseline and 20 weeks ]Assessed by questionnaire

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Ages Eligible for Study: | 4 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Denmark | |
Department of Nutrition, Exercise and Sports | |
Copenhagen, Frederiksberg, Denmark, 1958 |
Principal Investigator: | Christian Mølgaard, PhD, MD | Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen |
Responsible Party: | Christian Mølgaard, MD, Associate Professor, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT02145195 |
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 |
Vitamin D Children Supplements Cardiometabolic markers |
Immune defense Bone turnover Muscle strength |
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Cholecalciferol |
Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |