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

• ClinicalTrials.gov Identifier: NCT02145195
• Recruitment Status: Completed
• First Posted: May 22, 2014
• Last Update Posted: March 25, 2015
• Sponsor: University of Copenhagen
• Collaborators: University College Cork; University of Surrey
• Information provided by (Responsible Party): Christian Mølgaard, University of Copenhagen

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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency	Dietary Supplement: Vitamin D3 (cholecalciferol)	Not Applicable

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin D (10 microgram/day); Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.	Dietary Supplement: Vitamin D3 (cholecalciferol)
Experimental: Vitamin D (20 microgram/day); Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks.	Dietary Supplement: Vitamin D3 (cholecalciferol)
Placebo Comparator: Placebo control; Tablets with 0 microgram vitamin D daily for 20 weeks.

Outcome Measures

Primary Outcome Measures :

1. Change in vitamin D status [ Time Frame: Baseline and 20 weeks ]
   Serum concentrations of total 25-hydroxyvitamin D [25(OH)D]

Secondary Outcome Measures :

1. Change in anthropometric measurements [ Time Frame: Baseline and 20 weeks ]
   Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores.
2. 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).
3. 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.

Other Outcome Measures:

1. Change in cardio-metabolic markers [ Time Frame: Baseline and 20 weeks ]
   Blood pressure, insulin, cholesterols etc.
2. 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.
3. Change in muscle strength [ Time Frame: Baseline and 20 weeks ]
   Maximum hand grip strength.
4. Dietary intake of vitamin D and calcium [ Time Frame: Baseline and 20 weeks ]
   Assessed by questionnaire

Eligibility Criteria

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

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

Contacts and Locations

Locations

Denmark

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, Denmark, 1958

Sponsors and Collaborators

University of Copenhagen

University College Cork

University of Surrey

Investigators

• Principal Investigator: Christian Mølgaard, PhD, MD; Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mortensen C, Mølgaard 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.

Hauger H, Mølgaard C, Mortensen C, Ritz C, Frøkiær H, Smith TJ, Hart K, Lanham-New SA, Damsgaard CT. Winter Cholecalciferol Supplementation at 55°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.

Mortensen C, Mølgaard C, Hauger H, Kristensen M, Damsgaard CT. Winter vitamin D(3) 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.

Mortensen C, Damsgaard CT, Hauger H, Ritz C, Lanham-New SA, Smith TJ, Hennessy Á, Dowling K, Cashman KD, Kiely M, Mølgaard 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. Epub 2016 Oct 12.

• Responsible Party: Christian Mølgaard, MD, Associate Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT02145195 History of Changes
• Other Study ID Numbers: D214; European Commission ( Other Grant/Funding Number: Contract no. 613977 )
• First Posted: May 22, 2014
• Last Update Posted: March 25, 2015
• Last Verified: March 2015

Keywords provided by Christian Mølgaard, University of Copenhagen:

Vitamin D; Children; Supplements; Cardiometabolic markers; Immune defense; Bone turnover; Muscle strength

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents