Edible Oils in the Treatment of Constipation of Hemodialysis Patients

Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Mineral oil; Dietary supplement: Olive oil; Dietary supplement: Flaxseed oil

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04039-000
    • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mineral oil; 4ml daily (adjusted as needed), for 4 weeks	Other: Mineral oil; 4 ml daily (adjusted as needed), for 4 weeks
Active Comparator: Olive oil; 4ml daily (adjusted as needed), for 4 weeks	Dietary supplement: Olive oil; 4 ml daily (adjusted as needed), for 4 weeks
Active Comparator: Flaxseed oil; 4 ml daily (adjusted as needed), for 4 weeks	Dietary supplement: Flaxseed oil; 4 ml daily (adjusted as needed), for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of constipation symptoms	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.	1 month

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Principal Investigator: Lilian Cuppari, PhD, Federal University of São Paulo; Principal Investigator: Christiane I Ramos, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Constipation; Hemodialysis; Rome III criteria
• Additional Relevant MeSH Terms: Urologic Diseases; Signs and Symptoms, Digestive; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Constipation; Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: 2012/06605-9