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

NCT02212223 | Completed

• 1 other identifier: Helsinki U
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Serum 25-hydroxyvitamin D Concentrations (25OHD)

Keywords

Vitamin D; Serum 25-hydroxyvitamin D (25OHD); Dietary supplement; Ethnicity; Immigrant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Serum calcium concentration

  Change from baseline in serum calcium concentration at 3 and 6 months

• Serum parathyroid hormone (PTH) concentration

  Change from baseline in serum PTH concentration at 3 and 6 months

Other Outcomes (1)

• Polymorphisms in genes involved in the transport and metabolism of vitamin D

  Baseline

Study Arms (6)

Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3

EXPERIMENTAL

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

Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3

EXPERIMENTAL

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

Group 3: Somali immigrant group, 0 µg vitamin D3

PLACEBO COMPARATOR

Subjects belonging to Somali immigrant population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months

Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3

EXPERIMENTAL

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

Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3

EXPERIMENTAL

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

Group 6: Original Finnish group, 0 µg vitamin D3

PLACEBO COMPARATOR

Subjects belonging to original Finnish population are given a daily supplement containing 0 µg (0 IU) vitamin D3 to take for 6 months.

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Group 1: Somali immigrant group, 10 µg (400 IU) vitamin D3; Group 2: Somali immigrant group, 20 µg (800 IU) vitamin D3; Group 4: Original Finnish group, 10 µg (400 IU) vitamin D3; Group 5: Original Finnish group, 20 µg (800 IU) vitamin D3

Eligibility Criteria

• Age: 21 Years - 66 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Helsinki: lead
• University College Cork: collaborator
• Technical University of Denmark: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

Department of Food and Environmental Sciences, University of Helsinki

Helsinki, Finland

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Christel Lamberg-Allardt, Professor

  University of Helsinki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

FI (1)