Skip to main content
Clinical Trials/NCT01696526
NCT01696526CompletedNot Applicable

Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers

Ulrike Lehmann2 sites in 1 country53 target enrollmentStarted: October 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
53
Locations
2
Primary Endpoint
change of 25-hydroxvitamin D

Study Overview

Brief Summary

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

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

change of 25-hydroxvitamin D

Time Frame: after 4 weeks of consumption

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ulrike Lehmann
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ulrike Lehmann

Scientist

Martin-Luther-Universität Halle-Wittenberg

Study Sites (2)

Loading locations...

Similar Trials