Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ulrike Lehmann, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01696526
First received: September 27, 2012
Last updated: December 19, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • change of 25-hydroxvitamin D [ Time Frame: after 4 weeks of consumption ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ulrike Lehmann, Scientist, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01696526     History of Changes
Other Study ID Numbers: BMBF 0315668
Study First Received: September 27, 2012
Last Updated: December 19, 2012
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by 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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014