Edible Oils in the Treatment of Constipation of Hemodialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103556
• Other study ID #: 2012/06605-9
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: April 1, 2014
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Constipation
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Mineral oil
4 ml daily (adjusted as needed), for 4 weeks

Dietary Supplement:
• Olive oil
4 ml daily (adjusted as needed), for 4 weeks
• Flaxseed oil
4 ml daily (adjusted as needed), for 4 weeks

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No