Edible Oils in the Treatment of Constipation of Hemodialysis Patients

NCT ID: NCT02103556

Last Updated: 2014-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Mineral oil

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

Group Type ACTIVE_COMPARATOR

Mineral oil

Intervention Type OTHER

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

Olive oil

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

Group Type ACTIVE_COMPARATOR

Olive oil

Intervention Type DIETARY_SUPPLEMENT

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

Flaxseed oil

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

Group Type ACTIVE_COMPARATOR

Flaxseed oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Mineral oil

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

Intervention Type OTHER

Olive oil

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

Intervention Type DIETARY_SUPPLEMENT

Flaxseed oil

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Lilian Cuppari

Affiliate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lilian Cuppari, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Christiane I Ramos

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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2012/06605-9

Identifier Type: -

Identifier Source: org_study_id

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