Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

vitamin D fortified fish

+ conventional fish

Other
Who is being recruted

Avitaminosis+3

+ Deficiency Diseases

+ Nutrition Disorders

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Placebo-Controlled
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorUlrike Lehmann
Last updated: December 20, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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

Principal SponsorUlrike Lehmann
Last updated: December 20, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

53 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AvitaminosisDeficiency DiseasesNutrition DisordersNutritional and Metabolic DiseasesMalnutritionVitamin D Deficiency

Criteria

2 inclusion criteria required to participate
18 years

healthy

6 exclusion criteria prevent from participating
chronical illness (diabetes, kidney diseases, cardiovascular diseases)

hypercalcemia

hypercalciuria

pregnancy or breastfeeding women

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Human volunteers receiving vitamin D fortified fish, 4 weeks

Group II

Placebo
consumption of conventional fish , 4 weeks

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Naturwissenschaftliche Fakultät

Halle, GermanyOpen Naturwissenschaftliche Fakultät in Google Maps
CompletedOne Study Center