Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

Ulrike Lehmann

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: conventional fish; Other: vitamin D fortified fish

Study type: Interventional

Funder types: Other

Identifiers

NCT01696526

BMBF 0315668

Details and patient eligibility

About

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.

Full 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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups, including a placebo group

vitamin D fortified fish

Experimental group

Description:

Human volunteers receiving vitamin D fortified fish, 4 weeks

Treatment:

Other: vitamin D fortified fish

conventional fish

Placebo Comparator group

Description:

consumption of conventional fish , 4 weeks

Treatment:

Other: conventional fish