Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University College Cork | OTHER |
| Technical University of Denmark | OTHER |
| Finnish Institute for Health and Welfare | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Insufficient intake of vitamin D is a public health problem, affecting about 40% of the Finnish population in the winter. Vitamin D has a wide range of health effects: in addition to its effect on bone, it is known to affect inflammatory response among other things. The sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements. In Finland and in Northern Europe vitamin D is formed in the skin only from March to October. This alone is not sufficient to cover the need for year-round, because vitamin D storage is used in a few months. During the winter months the only sources of vitamin D are diet and vitamin preparations. Current vitamin D recommendations are usually based on studies in white population. However, there can be a difference in the need of vitamin D and in vitamin D metabolism between different population groups. More research evidence is needed from the northern countries. The aim of this study is to evaluate the vitamin D need in Somali immigrant population and in original Finnish population. The hypothesis is that the Somalis need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original Finnish population.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3 | Experimental | Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months |
|
| Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3 | Experimental | Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months |
|
| Group 3: Somali immigrant group, 0 µg vitamin D3 | Placebo Comparator | Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months | |
| Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3 | Experimental | Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months. |
|
| Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3 | Experimental | Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum 25-hydroxyvitamin D (25(OH)D) concentrations | The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated. | Change from baseline in serum 25(OH)D concentration at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum calcium concentration | Markers of calcium metabolism, which are affected by vitamin D, will be measured | Change from baseline in serum calcium concentration at 3 and 6 months |
| Serum parathyroid hormone (PTH) concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Polymorphisms in genes involved in the transport and metabolism of vitamin D | Genomic DNA will be isolated and single nucleotide polymorphisms (SNPs) for key genes involved in vitamin D transport and metabolism will be measured to investigate the ethnic variation in the genes. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christel Lamberg-Allardt, Professor | University of Helsinki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Environmental Sciences, University of Helsinki | Helsinki | Finland |
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Group 6: Original Finnish group, 0 µg vitamin D3 | Placebo Comparator | Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months. |
Markers of calcium metabolism, which are affected by vitamin D, will be measured
| Change from baseline in serum PTH concentration at 3 and 6 months |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |