Bioefficiency of of Conventional Fish and Vitamin D Forti... | NCT01696526

Studies
Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish

NCT01696526

Sponsor

Ulrike Lehmann

Status

Completed

Last Update Posted

Dec 20, 2012Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Vitamin D Deficiency

Interventions

vitamin D fortified fish
conventional fish

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Sep 28, 2012

First Posted Date

Oct 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2012

Last Update Posted Date

Dec 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
vitamin D fortified fish	Other	fish containing vitamin D3	vitamin D fortified fish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of 25-hydroxvitamin D		after 4 weeks of consumption

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriele I. Stangl, Prof.	Institut für Agrar- und Ernährungswissenschaften	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Naturwissenschaftliche Fakultät		Halle	Saxony-Anhalt	06120	Germany

Condition Browse Module

MeSH Terms

ID	Term
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D001361	Avitaminosis
D003677	Deficiency Diseases
D044342	Malnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided