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| ID | Type | Description | Link |
|---|---|---|---|
| European Commission | Other Grant/Funding Number | Contract no. 613977 |
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| Name | Class |
|---|---|
| University College Cork | OTHER |
| University of Surrey | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D (10 microgram/day) | Experimental | Tablets with 10 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. |
|
| Vitamin D (20 microgram/day) | Experimental | Tablets with 20 microgram vitamin D3 (cholecalciferol) daily for 20 weeks. |
|
| Placebo control | Placebo Comparator | Tablets with 0 microgram vitamin D daily for 20 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (cholecalciferol) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in vitamin D status | Serum concentrations of total 25-hydroxyvitamin D [25(OH)D] | Baseline and 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anthropometric measurements | Waist circumference, body weight, height, body mass index (BMI) and BMI z-scores. | Baseline and 20 weeks |
| Change in body composition | Fat mass, fat mass index (kg/m2), fat free mass and fat free mass index (kg/m2). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardio-metabolic markers | Blood pressure, insulin, cholesterols etc. | Baseline and 20 weeks |
| Change in markers of immune defense | Production of cytokines in whole blood cultures. Expression of immune markers and antiviral and antimicrobial peptides. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Mølgaard, PhD, MD | Section of Peadiatric and International Nutrition, Department of Nutrition, Exercise and Sports, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Exercise and Sports | Copenhagen | Frederiksberg | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30189911 | Derived | 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. | |
| 29917069 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 12, 2018 | |
| Reset | Dec 20, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 12, 2018 | Dec 20, 2018 |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Baseline and 20 weeks |
| Serum calcium | Serum calcium (adjusted for albumin) evaluated after the first visit has been completed for all children, and after the second visit. | Baseline and 20 weeks |
| Baseline and 20 weeks |
| Change in muscle strength | Maximum hand grip strength. | Baseline and 20 weeks |
| Dietary intake of vitamin D and calcium | Assessed by questionnaire | Baseline and 20 weeks |
| 29450728 | Derived | 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. |
| 27733403 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |