NCT02103556

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

March 10, 2014

Last Update Submit

April 1, 2014

Conditions

Chronic Kidney Disease

Keywords

ConstipationRome III criteriaHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Score of constipation symptoms

    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.

    1 month

Study Arms (3)

Mineral oil

ACTIVE COMPARATOR

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

Other: Mineral oil

Olive oil

ACTIVE COMPARATOR

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

Dietary Supplement: Olive oil

Flaxseed oil

ACTIVE COMPARATOR

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

Dietary Supplement: Flaxseed oil

Interventions

Mineral oilOTHER

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

Mineral oil
Olive oilDIETARY_SUPPLEMENT

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

Olive oil
Flaxseed oilDIETARY_SUPPLEMENT

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

Flaxseed oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Constipated patients by Rome III criteria
  • Hemodialysis \> 3 months

You may not qualify if:

  • Diagnosis of gastrointestinal disease other than constipation
  • Previous intolerance to the oils used in the study
  • Cognitive limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04039-000, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicConstipation

Interventions

Mineral OilOlive OilLinseed Oil

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

PetrolatumHydrocarbonsOrganic ChemicalsDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Lilian Cuppari, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Christiane I Ramos

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliate Professor

Study Record Dates

First Submitted

March 10, 2014

First Posted

April 4, 2014

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

BR(1)