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

July 12, 2015 updated by: Christel Lamberg-Allardt, University of Helsinki

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Department of Food and Environmental Sciences, University of Helsinki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
Change from baseline in serum calcium concentration at 3 and 6 months
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
Change from baseline in serum PTH concentration at 3 and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

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

Investigators

  • Study Director: Christel Lamberg-Allardt, Professor, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 12, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Helsinki U

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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