Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696526
• Other study ID #: BMBF 0315668
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: December 19, 2012
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• vitamin D fortified fish
fish containing vitamin D3
• conventional fish
fish containing low concentrations of vitamin D3

Locations

Country	Name	City	State
Germany	Naturwissenschaftliche Fakultät	Halle/Saale	Sachsen Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Ulrike Lehmann

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of 25-hydroxvitamin D		after 4 weeks of consumption	No