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Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
vitamin D fortified fish
conventional fish
Sponsored by
Ulrike Lehmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vitamin D Deficiency focused on measuring vitamin D, bioeffiency, vitamin d fortified fish

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Naturwissenschaftliche Fakultät

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin D fortified fish

conventional fish

Arm Description

Human volunteers receiving vitamin D fortified fish, 4 weeks

consumption of conventional fish , 4 weeks

Outcomes

Primary Outcome Measures

change of 25-hydroxvitamin D

Secondary Outcome Measures

Full Information

First Posted
September 27, 2012
Last Updated
December 19, 2012
Sponsor
Ulrike Lehmann
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1. Study Identification

Unique Protocol Identification Number
NCT01696526
Brief Title
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish
Official Title
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ulrike Lehmann

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, bioeffiency, vitamin d fortified fish

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin D fortified fish
Arm Type
Experimental
Arm Description
Human volunteers receiving vitamin D fortified fish, 4 weeks
Arm Title
conventional fish
Arm Type
Placebo Comparator
Arm Description
consumption of conventional fish , 4 weeks
Intervention Type
Other
Intervention Name(s)
vitamin D fortified fish
Other Intervention Name(s)
intervention
Intervention Description
fish containing vitamin D3
Intervention Type
Other
Intervention Name(s)
conventional fish
Other Intervention Name(s)
placebo
Intervention Description
fish containing low concentrations of vitamin D3
Primary Outcome Measure Information:
Title
change of 25-hydroxvitamin D
Time Frame
after 4 weeks of consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele I. Stangl, Prof.
Organizational Affiliation
Institut für Agrar- und Ernährungswissenschaften
Official's Role
Study Director
Facility Information:
Facility Name
Naturwissenschaftliche Fakultät
City
Halle/Saale
State/Province
Sachsen Anhalt
ZIP/Postal Code
06120
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

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