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 Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: vitamin D fortified fish; Other: conventional fish

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

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Sachsen Anhalt
    • Halle/Saale, Sachsen Anhalt, Germany, 06120
      • Naturwissenschaftliche Fakultät

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitamin D fortified fish; Human volunteers receiving vitamin D fortified fish, 4 weeks	Other: vitamin D fortified fish; fish containing vitamin D3; Other Names: intervention
Placebo Comparator: conventional fish; consumption of conventional fish , 4 weeks	Other: conventional fish; fish containing low concentrations of vitamin D3; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of 25-hydroxvitamin D	after 4 weeks of consumption

Collaborators and Investigators

• Sponsor: Ulrike Lehmann
• Investigators: Study Director: Gabriele I. Stangl, Prof., Institut für Agrar- und Ernährungswissenschaften

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 28, 2012
• First Posted (Estimate): October 1, 2012

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: vitamin D; bioeffiency; vitamin d fortified fish
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: BMBF 0315668