Edible Oils in the Treatment of Constipation of Hemodialysis Patients

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Mineral oil; Dietary Supplement: Flaxseed oil; Dietary Supplement: Olive oil

• Registration Number: NCT02103556
• Lead Sponsor: Federal University of São Paulo

Brief Summary

The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2014-03-10
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-01
• Last Update Submitted: 2014-04-01
• Study First Posted: 2014-04-04
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Constipated patients by Rome III criteria
• Hemodialysis > 3 months

Exclusion Criteria

• Diagnosis of gastrointestinal disease other than constipation
• Previous intolerance to the oils used in the study
• Cognitive limitations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral oil	Mineral oil	4ml daily (adjusted as needed), for 4 weeks
Flaxseed oil	Flaxseed oil	4 ml daily (adjusted as needed), for 4 weeks
Olive oil	Olive oil	4ml daily (adjusted as needed), for 4 weeks

Primary Outcome Measures

Name	Time	Method
Score of constipation symptoms	1 month	Constipation was diagnosed by the Rome III criterion. The diagnosis consists in the presence, for at least three months, of two or more of the following symptoms: "fewer than three evacuations per week", "straining on evacuation", "lumpy or hard stools", "incomplete evacuation", "anorectal obstruction" and use of "manual maneuvers" to facilitate evacuation. Each symptom is scored as: 0=never or rarely, 1=sometimes, 2=often, 3=most of the time and 4=always. In the present study, the frequency of the symptoms was considered as a continuous variable and, a final score ranging from 0 to 24 was calculated. Lowest scores were indicative of fewer symptoms of constipation.

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil