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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014