Skip to main content
OpenTrials
Completed

NCT Number: NCT02212223

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–66 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Environmental Sciences, University of Helsinki

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Primary outcomes

  1. Serum 25-hydroxyvitamin D (25(OH)D) concentrations

    Time frame: 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 outcomes

  1. Serum calcium concentration

    Time frame: 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

  2. Serum parathyroid hormone (PTH) concentration

    Time frame: 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

Other outcomes

  1. Polymorphisms in genes involved in the transport and metabolism of vitamin D

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Finnish Institute for Health and Welfare
  • Technical University of Denmark
  • University College Cork

Registry information

Official study title

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

Acronym: ODIN

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2014
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.