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Coffee in Hemodialysis and Headache

NCT04057313 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2020-10-14

No results posted yet for this study

Summary

Coffee is the most consumed drink worldwide, sometimes needed to boost energy and other times to entertain social connectivity. Caffeine is mostly present unbound in the plasma, only 10 to 30% of caffeine binds to plasma proteins. It is distributed freely into the intracellular space, and it has a small distribution volume. Therefore, caffeine can pass through the dialysis membrane during a standard hemodialysis session. In hemodialysis patients, headache occurs in 40 to 75% of patients. Some authors have suggested that one of the reasons of headache during hemodialysis is caffeine withdrawal. This trial aims to find whether coffee intake during hemodialysis reduces the headache episodes. It is a randomized double blind multicenter trial where 160 patients will be randomized to 2 groups: group 1 of 80 patients will be given a cup of coffee each dialysis session for 4 weeks and group 2 will receive decaffeinated coffee each dialysis session for 4 weeks.

Conditions

  • Hemodialysis Complication

Interventions

DIETARY_SUPPLEMENT

Coffee

Coffee used will be the boiled unfiltered Arabica coffee

Sponsors & Collaborators

  • Saint-Joseph University

    lead OTHER

Principal Investigators

  • Mabel Aoun, MD · Saint-Joseph University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057313 on ClinicalTrials.gov