Serum 25-hydroxyvitamin D Concentrations (25OHD) Clinical Trial
— ODINOfficial title:
Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
Verified date | July 2015 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 66 Years |
Eligibility |
Inclusion Criteria: - woman between 21-66 years of age - belongs to original Finnish population or to Somali immigrant population - healthy (= no disease requiring medication) - lives in the metropolitan area Exclusion Criteria: - pregnant or breastfeeding - has traveled to a sunny destination or destination near the equator during the previous month - plans to travel to a sunny destination or destination near the equator in the next 6 months - has used a tanning bed during the previous month - plans to use a tanning bed in the next 6 months - the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or is less than 30 nmol / L at baseline in the screening phase. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Department of Food and Environmental Sciences, University of Helsinki | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | National Institute for Health and Welfare, Finland, Technical University of Denmark, University College Cork |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Serum parathyroid hormone (PTH) concentration | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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