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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02103556
Enrollment
50
Registered
2014-04-04
Start date
2012-04-30
Completion date
2013-04-30
Last updated
2014-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Constipation, Rome III criteria, Hemodialysis

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.

Interventions

4 ml daily (adjusted as needed), for 4 weeks

DIETARY_SUPPLEMENTOlive oil

4 ml daily (adjusted as needed), for 4 weeks

DIETARY_SUPPLEMENTFlaxseed oil

4 ml daily (adjusted as needed), for 4 weeks

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Score of constipation symptoms1 monthConstipation 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026