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Completed

NCT Number: NCT02103556

Edible Oils in the Treatment of 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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Constipation Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04039-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Score of constipation symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2014
Registry last updated
Apr 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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