NCT01696526CompletedNot Applicable
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
Ulrike Lehmann2 sites in 1 country53 target enrollmentStarted: October 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 2
- Primary Endpoint
- change of 25-hydroxvitamin D
Study Overview
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
- Placebo group receiving conventional fish
- intervention group receiving vitamin D fortified fish
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Outcomes
Primary Outcomes
change of 25-hydroxvitamin D
Time Frame: after 4 weeks of consumption
Secondary Outcomes
No secondary outcomes reported
Investigators
Ulrike Lehmann
Scientist
Martin-Luther-Universität Halle-Wittenberg
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in NorwayHealthyNCT01482689University of Oslo74
Completed
Not Applicable
Vitamin D Enriched Meat Project (Acute Study)Vitamin D DeficiencyNCT04207294University of Ulster15
Completed
Not Applicable
Safety and Bioefficacy of Vitamin D2 and Vitamin D3Vitamin D DeficiencyNCT01503216Ulrike Lehmann120
Completed
Not Applicable
Vitamin D in Healthy Adults After Strenuous Endurance ExerciseHealthyNCT05779410Taipei Medical University35
Completed
Not Applicable
Bioavailability and Biological Effects of Vitamin D2 Contained in MushroomVitamin D DeficiencyMetabolic SyndromePrediabetesNCT01488734Icahn School of Medicine at Mount Sinai47