Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: conventional fish; Other: vitamin D fortified fish

• Registration Number: NCT01696526
• Lead Sponsor: Ulrike Lehmann

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-09-28
• Study Start: 2012-10
• Study First Posted: 2012-10-01
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional fish	conventional fish	consumption of conventional fish , 4 weeks
vitamin D fortified fish	vitamin D fortified fish	Human volunteers receiving vitamin D fortified fish, 4 weeks

Primary Outcome Measures

Name	Time	Method
change of 25-hydroxvitamin D	after 4 weeks of consumption

Trial Locations

Locations (1)

Naturwissenschaftliche Fakultät; 🇩🇪 Halle/Saale, Sachsen Anhalt, Germany