NCT00835887

Brief Summary

In this study, the acute and long-term effects of flavanols on vascular function in patients with ESRD will be investigated.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

First QC Date

February 3, 2009

Last Update Submit

September 22, 2015

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

  • Vascular function

    before treatment, directly after treatment and 3, resp. 4 months afterwards

Study Arms (2)

1

EXPERIMENTAL

Treatment with low dose flavanoids

Dietary Supplement: low and high dose flavanoids

2

EXPERIMENTAL

Treatment with high dose flavanoids

Dietary Supplement: low and high dose flavanoids

Interventions

low and high dose flavanoidsDIETARY_SUPPLEMENT

treatment with flavanoid-rich or flavanoid-low cacao twice daily

12

Eligibility Criteria

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

You may qualify if:

  • patients with end stage renal disease

You may not qualify if:

  • person under 18 years of age
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Düsseldorf University Hospital

Düsseldorf, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)