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Completed

NCT Number: NCT01696526

Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naturwissenschaftliche Fakultät

Halle, Saxony-Anhalt, 06120, Germany

About this study

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

  • Placebo group receiving conventional fish
  • intervention group receiving vitamin D fortified fish

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D fortified fish

Other

fish containing vitamin D3

Other names: intervention

conventional fish

Other

fish containing low concentrations of vitamin D3

Other names: placebo

Primary outcomes

  1. change of 25-hydroxvitamin D

    Time frame: after 4 weeks of consumption

Sponsors and collaborators

Lead sponsor

Ulrike Lehmann

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2012
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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