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

Serum 25-hydroxyvitamin D Concentrations (25OHD) Clinical Trial

— ODIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212223
• Other study ID #: Helsinki U
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: July 12, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 66 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Serum 25-hydroxyvitamin D Concentrations (25OHD)

Intervention

Dietary Supplement:
• Vitamin D3

Locations

Country	Name	City	State
Finland	Department of Food and Environmental Sciences, University of Helsinki	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University	National Institute for Health and Welfare, Finland, Technical University of Denmark, University College Cork

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Polymorphisms in genes involved in the transport and metabolism of vitamin D	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No