Effects of Xanthophylls on Optical Density | NCT01316198

Studies
Effects of Xanthophylls on Optical Density

NCT01316198

Sponsor

University of Jena

Status

Completed

Last Update Posted

Jul 27, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration

Interventions

Verum
Placebo

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

Jul 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

Jun 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Mar 15, 2011

First Submission Date that Met QC Criteria

Mar 15, 2011

First Posted Date

Mar 16, 2011Estimated

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

Jul 26, 2012

Last Update Posted Date

Jul 27, 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 objective of the study was to investigate the influence of a intervention with lutein und zeaxanthin from crucifers on the optical density of the macular pigment of patients with non exudative age-related maculopathy. It is hypothesized that the applied study beverage elevates plasma concentrations of the administered xanthophylls and the optical density after 4 weeks of intervention.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lutein and zeaxanthin	Experimental		Dietary Supplement: Verum
Placebo	Experimental		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Verum	Dietary Supplement	10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day	Lutein and zeaxanthin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optical density of macular pigment in AMD patients		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Concentration of xanthophylls in plasma of AMD patients		10 weeks
blood lipids		10 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with non exudative age-related maculopathy

Exclusion Criteria:

intake of dietary supplements containing lutein and zeaxanthin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Volker Boehm, Dr.	Friedrich Schiller University Jena, Institute of Nutrition, RG Bioactice Plant Products	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Friedrich Schiller University		Jena	Thuringia	07743	Germany

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C068637	calcium D-pantothenate, L-cysteine drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided