NCT01696526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

2 months

First QC Date

September 27, 2012

Last Update Submit

December 19, 2012

Conditions

Vitamin D Deficiency

Keywords

vitamin Dbioeffiencyvitamin d fortified fish

Outcome Measures

Primary Outcomes (1)

  • change of 25-hydroxvitamin D

    after 4 weeks of consumption

Study Arms (2)

vitamin D fortified fish

EXPERIMENTAL

Human volunteers receiving vitamin D fortified fish, 4 weeks

Other: vitamin D fortified fish

conventional fish

PLACEBO COMPARATOR

consumption of conventional fish , 4 weeks

Other: conventional fish

Interventions

vitamin D fortified fishOTHER

fish containing vitamin D3

Also known as: intervention
vitamin D fortified fish
conventional fishOTHER

fish containing low concentrations of vitamin D3

Also known as: placebo
conventional fish

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naturwissenschaftliche Fakultät

Halle, Saxony-Anhalt, 06120, Germany

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Methods

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Gabriele I. Stangl, Prof.

    Institut für Agrar- und Ernährungswissenschaften

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

September 27, 2012

First Posted

October 1, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

DE(1)