Marwo-D Research -Need for Vitamin D in Different Population Groups
- Conditions
- Serum 25-hydroxyvitamin D Concentrations (25OHD)
- Interventions
- Dietary Supplement: Vitamin D3
- Registration Number
- NCT02212223
- Lead Sponsor
- University of Helsinki
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 147
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3 Vitamin D3 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 Vitamin D3 Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3 Vitamin D3 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 Vitamin D3 Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months.
- Primary Outcome Measures
Name Time Method Serum 25-hydroxyvitamin D (25(OH)D) concentrations Change from baseline in serum 25(OH)D concentration at 3 and 6 months The effect of ethnicity on the serum 25(OH)D concentration response to vitamin D supplementation will be investigated.
- Secondary Outcome Measures
Name Time Method Serum calcium concentration Change from baseline in serum calcium concentration at 3 and 6 months Markers of calcium metabolism, which are affected by vitamin D, will be measured
Serum parathyroid hormone (PTH) concentration Change from baseline in serum PTH concentration at 3 and 6 months Markers of calcium metabolism, which are affected by vitamin D, will be measured
Trial Locations
- Locations (1)
Department of Food and Environmental Sciences, University of Helsinki
🇫🇮Helsinki, Finland