Edible Oils in the Treatment of Constipation of Hemodialysis Patients

NCT02103556 — Not applicable, Completed, 50 participants, Federal University of São Paulo

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

Registry	NCT02103556
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	50 (Actual)
Sponsor	Federal University of São Paulo (Other); collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions	Chronic Kidney Disease
Interventions	Mineral oil, Olive oil, Flaxseed oil (Other, dietary supplement)
Dates	start 2012-04-01, primary completion 2013-04-01, completion 2013-04-01, first posted 2014-04-04, last updated 2014-04-04
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Mineral oil	Active comparator	Other: Mineral oil	4ml daily (adjusted as needed), for 4 weeks
Olive oil	Active comparator	Dietary Supplement: Olive oil	4ml daily (adjusted as needed), for 4 weeks
Flaxseed oil	Active comparator	Dietary Supplement: Flaxseed oil	4 ml daily (adjusted as needed), for 4 weeks

Mineral oil (Other): 4 ml daily (adjusted as needed), for 4 weeks
Olive oil (Dietary supplement): 4 ml daily (adjusted as needed), for 4 weeks
Flaxseed oil (Dietary supplement): 4 ml daily (adjusted as needed), for 4 weeks

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Federal University of São Paulo	São Paulo, São Paulo	Brazil

+Investigators

Lilian Cuppari, PhD, Principal investigator, Federal University of São Paulo
Christiane I Ramos, Principal investigator, Federal University of São Paulo

My Notes

Public

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