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Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

NCT ID: NCT01696526

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-12-31

Brief Summary

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The aim of this study is to investigate the bioavailability of conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.

Detailed Description

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Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.

Groups/Cohorts Assigned Interventions

1. Placebo group receiving conventional fish
2. intervention group receiving vitamin D fortified fish

Conditions

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Vitamin D Deficiency

Keywords

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vitamin D bioeffiency vitamin d fortified fish

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vitamin D fortified fish

Human volunteers receiving vitamin D fortified fish, 4 weeks

Group Type EXPERIMENTAL

vitamin D fortified fish

Intervention Type OTHER

fish containing vitamin D3

conventional fish

consumption of conventional fish , 4 weeks

Group Type PLACEBO_COMPARATOR

conventional fish

Intervention Type OTHER

fish containing low concentrations of vitamin D3

Interventions

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vitamin D fortified fish

fish containing vitamin D3

Intervention Type OTHER

conventional fish

fish containing low concentrations of vitamin D3

Intervention Type OTHER

Other Intervention Names

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intervention placebo

Eligibility Criteria

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Inclusion Criteria

* 18 years
* healthy

Exclusion Criteria

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ulrike Lehmann

OTHER

Sponsor Role lead

Responsible Party

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Ulrike Lehmann

Scientist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gabriele I. Stangl, Prof.

Role: STUDY_DIRECTOR

Institut für Agrar- und Ernährungswissenschaften

Locations

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Naturwissenschaftliche Fakultät

Halle, Saxony-Anhalt, Germany

Site Status

Countries

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Germany

Other Identifiers

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BMBF 0315668

Identifier Type: -

Identifier Source: org_study_id