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Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01696526
First Posted: October 1, 2012
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
September 27, 2012
October 1, 2012
December 20, 2012
October 2012
December 2012   (Final data collection date for primary outcome measure)
change of 25-hydroxvitamin D [ Time Frame: after 4 weeks of consumption ]
Same as current
Complete list of historical versions of study NCT01696526 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Vitamin D Deficiency
  • Other: vitamin D fortified fish
    fish containing vitamin D3
    Other Name: intervention
  • Other: conventional fish
    fish containing low concentrations of vitamin D3
    Other Name: placebo
  • Experimental: vitamin D fortified fish
    Human volunteers receiving vitamin D fortified fish, 4 weeks
    Intervention: Other: vitamin D fortified fish
  • Placebo Comparator: conventional fish
    consumption of conventional fish , 4 weeks
    Intervention: Other: conventional fish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01696526
BMBF 0315668
Yes
Not Provided
Not Provided
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
Ulrike Lehmann
Not Provided
Study Director: Gabriele I. Stangl, Prof. Institut für Agrar- und Ernährungswissenschaften
Martin-Luther-Universität Halle-Wittenberg
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP