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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015940-40 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
The aims of the present study are to evaluate the concentrations of vitamin D in the plasma and of calcium in the plasma and in the urine as well as to evaluate bone mineral density using peripheral quantitative computed tomography (pQCT), after supplementation of vitamin D with 30µg (1200 IU) and 40µg (1600 IU), in comparison with currently recommended supplementation of vitamin D with 10µg (400 IU). In this pilot study supplementation is given to infants from 2 weeks of age to 3 months of age.
Vitamin D deficiency is common around the world. In Finland vitamin D levels are low in all age groups. Especially infants are predisposed to vitamin D deficiency. Partly this is due to low exposure to sunlight but mainly it is due to low dietary intake of vitamin D. Vitamin D prophylaxis was introduced in Finland in the 1950´s to overcome rickets. However, the recommended dose has decreased from 50µg (2000 IU) in the 1960´s to 10µg (400 IU) from beginning of the 1990´s. The serum concentration of 25-hydroxyvitamin D (S-25OHD) is used as a marker of vitamin D status in the body. Although there is no consensus of optimal concentration of S-25OHD, it has been proposed that concentrations lower than 50 nmol/l indicate deficiency. According to recent findings on 25-OHD concentrations in Finnish children, currently recommended intake of vitamin D is inadequate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 10µg | Active Comparator |
| |
| Vitamin D3 30µg | Active Comparator |
| |
| Vitamin D3 40µg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol (D3) | Dietary Supplement | 10µg (400 IU) orally daily for 10 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| S-25OHD concentration after vitamin D supplementation to infants | The primary endpoint is the concentration of 25OHD in serum after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). Vitamin D supplementation is given to infants from 2 weeks of age to 3 months of age. | after 10 weeks of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| concentration of calcium in the plasma and in the urine | Incidence of hypercalcemia and hypercalciuria in infants after daily supplementation with vitamin D (10µg / 30µg / 40µg orally). | after 10 weeks of supplementation |
| bone mineral density |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sture Andersson, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Children and Adolescents, Helsinki University Central Hospital | Helsinki | 00029 | Finland |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| cholecalciferol (D3) |
| Dietary Supplement |
30µg (1200 IU) orally daily for 10 weeks |
|
| cholecalciferol (D3) | Dietary Supplement | 40µg (1600 IU) orally daily for 10 weeks |
|
Measurement of bone mineral density using peripheral quantitative computed tomography (pQCT), after daily supplementation with vitamin D (10µg / 30µg / 40µg orally).
| after 10 weeks of supplementation |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |