Marwo-D Research -Need for Vitamin D in Different Population Groups

Study Overview
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Brief Summary
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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.

Official Title
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Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)

Conditions
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Serum 25-hydroxyvitamin D Concentrations (25OHD)

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3<br>Subjects belonging to Somali immigrant population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months | Dietary Supplement: Vitamin D3<br> <br> |
| Experimental: Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3<br>Subjects belonging to Somali immigrant population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months | Dietary Supplement: Vitamin D3<br> <br> |
| Placebo Comparator: Group 3: Somali immigrant group, 0 µg vitamin D3<br>Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months | |
| Experimental: Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3<br>Subjects belonging to original Finnish population are given a daily supplement containing 10 µg (400 IU) vitamin D3 to take for 6 months. | Dietary Supplement: Vitamin D3<br> <br> |
| Experimental: Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3<br>Subjects belonging to original Finnish population are given a daily supplement containing 20 µg (800 IU) vitamin D3 to take for 6 months. | Dietary Supplement: Vitamin D3<br> <br> |
| Placebo Comparator: Group 6: Original Finnish group, 0 µg vitamin D3<br>Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Serum 25-hydroxyvitamin D (25OHD), Dietary supplement, Ethnicity, Immigrant