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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
  Purpose
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.

Condition Intervention
Vitamin D Deficiency Other: vitamin D fortified fish Other: conventional fish

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • change of 25-hydroxvitamin D [ Time Frame: after 4 weeks of consumption ]

Enrollment: 53
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vitamin D fortified fish
Human volunteers receiving vitamin D fortified fish, 4 weeks
Other: vitamin D fortified fish
fish containing vitamin D3
Other Name: intervention
Placebo Comparator: conventional fish
consumption of conventional fish , 4 weeks
Other: conventional fish
fish containing low concentrations of vitamin D3
Other Name: placebo

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696526


Locations
Germany
Naturwissenschaftliche Fakultät
Halle/Saale, Sachsen Anhalt, Germany, 06120
Sponsors and Collaborators
Ulrike Lehmann
Investigators
Study Director: Gabriele I. Stangl, Prof. Institut für Agrar- und Ernährungswissenschaften
  More Information

Responsible Party: Ulrike Lehmann, Scientist, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01696526     History of Changes
Other Study ID Numbers: BMBF 0315668
First Submitted: September 27, 2012
First Posted: October 1, 2012
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg:
vitamin D
bioeffiency
vitamin d fortified fish

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents