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Edible Oils in the Treatment of Constipation of Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103556
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Lilian Cuppari, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Mineral oil Dietary Supplement: Olive oil Dietary Supplement: Flaxseed oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients
Study Start Date : April 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mineral oil
4ml daily (adjusted as needed), for 4 weeks
Other: Mineral oil
4 ml daily (adjusted as needed), for 4 weeks

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

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103556


Locations
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Brazil
Federal University of São Paulo
São Paulo, Brazil, 04039-000
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Lilian Cuppari, PhD Federal University of São Paulo
Principal Investigator: Christiane I Ramos Federal University of São Paulo
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Responsible Party: Lilian Cuppari, Affiliate Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02103556    
Other Study ID Numbers: 2012/06605-9
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by Lilian Cuppari, Federal University of São Paulo:
Constipation
Rome III criteria
Hemodialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Constipation
Urologic Diseases
Renal Insufficiency
Signs and Symptoms, Digestive
Mineral Oil
Emollients
Dermatologic Agents