Clinical trial NCT02212223: Marwo-D Research -Need for Vitamin D in Different Population Groups
Official title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serum 25-hydroxyvitamin D Concentrations (25OHD)
Keywords: Vitamin D
Serum 25-hydroxyvitamin D (25OHD)
Dietary supplement
Ethnicity
Immigrant
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: University College Cork
name: Technical University of Denmark
name: Finnish Institute for Health and Welfare
First posted: 2014-08-08
Enrollment: 147
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum 25-hydroxyvitamin D (25(OH)D) concentrations
timeFrame: Change from baseline in serum 25(OH)D concentration at 3 and 6 months
Secondary outcomes:
measure: Serum calcium concentration
timeFrame: Change from baseline in serum calcium concentration at 3 and 6 months
measure: Serum parathyroid hormone (PTH) concentration
timeFrame: Change from baseline in serum PTH concentration at 3 and 6 months
Other outcomes:
measure: Polymorphisms in genes involved in the transport and metabolism of vitamin D
timeFrame: Baseline
Locations:
city: Helsinki
country: Finland
facility: Department of Food and Environmental Sciences, University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Christel Lamberg-Allardt, Professor
role: STUDY_DIRECTOR
References: