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Marwo-D Research -Need for Vitamin D in Different Population Groups (ODIN)

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ClinicalTrials.gov Identifier: NCT02212223
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : July 14, 2015
Sponsor:
Collaborators:
University College Cork
Technical University of Denmark
National Institute for Health and Welfare, Finland
Information provided by (Responsible Party):
Christel Lamberg-Allardt, Helsinki University

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.

Condition or disease Intervention/treatment Phase
Serum 25-hydroxyvitamin D Concentrations (25OHD) Dietary Supplement: Vitamin D3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
Study Start Date : September 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   21 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212223


Locations
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Finland
Department of Food and Environmental Sciences, University of Helsinki
Helsinki, Finland
Sponsors and Collaborators
Helsinki University
University College Cork
Technical University of Denmark
National Institute for Health and Welfare, Finland
Investigators
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Study Director: Christel Lamberg-Allardt, Professor Helsinki University

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Responsible Party: Christel Lamberg-Allardt, Associate Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT02212223     History of Changes
Other Study ID Numbers: Helsinki U
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by Christel Lamberg-Allardt, Helsinki University:
Vitamin D
Serum 25-hydroxyvitamin D (25OHD)
Dietary supplement
Ethnicity
Immigrant
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents