Back to resultsEdible Oils in the Treatment of Constipation of Hemodialysis Patients
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mineral oil
Olive oil
Flaxseed oil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Constipation, Rome III criteria, Hemodialysis
Eligibility Criteria
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
Sites / Locations
- Federal University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Mineral oil
Olive oil
Flaxseed oil
Arm Description
4ml daily (adjusted as needed), for 4 weeks
4ml daily (adjusted as needed), for 4 weeks
4 ml daily (adjusted as needed), for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02103556
First Posted
March 10, 2014
Last Updated
April 1, 2014
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02103556
Brief Title
Edible Oils in the Treatment of Constipation of Hemodialysis Patients
Official Title
Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Constipation, Rome III criteria, Hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mineral oil
Arm Type
Active Comparator
Arm Description
4ml daily (adjusted as needed), for 4 weeks
Arm Title
Olive oil
Arm Type
Active Comparator
Arm Description
4ml daily (adjusted as needed), for 4 weeks
Arm Title
Flaxseed oil
Arm Type
Active Comparator
Arm Description
4 ml daily (adjusted as needed), for 4 weeks
Intervention Type
Other
Intervention Name(s)
Mineral oil
Intervention Description
4 ml daily (adjusted as needed), for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Intervention Description
4 ml daily (adjusted as needed), for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Flaxseed oil
Intervention Description
4 ml daily (adjusted as needed), for 4 weeks
Primary Outcome Measure Information:
Title
Score of constipation symptoms
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilian Cuppari, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christiane I Ramos
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
ZIP/Postal Code
04039-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Edible Oils in the Treatment of Constipation of Hemodialysis Patients
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