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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

Tracking Information
First Submitted Date  ICMJE March 10, 2014
First Posted Date  ICMJE April 4, 2014
Last Update Posted Date April 4, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Edible Oils in the Treatment of Constipation of Hemodialysis Patients
Official Title  ICMJE Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • Other: Mineral oil
    4 ml daily (adjusted as needed), for 4 weeks
  • Dietary Supplement: Olive oil
    4 ml daily (adjusted as needed), for 4 weeks
  • Dietary Supplement: Flaxseed oil
    4 ml daily (adjusted as needed), for 4 weeks
Study Arms  ICMJE
  • Active Comparator: Mineral oil
    4ml daily (adjusted as needed), for 4 weeks
    Intervention: Other: Mineral oil
  • Active Comparator: Olive oil
    4ml daily (adjusted as needed), for 4 weeks
    Intervention: Dietary Supplement: Olive oil
  • Active Comparator: Flaxseed oil
    4 ml daily (adjusted as needed), for 4 weeks
    Intervention: Dietary Supplement: Flaxseed oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2014)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02103556
Other Study ID Numbers  ICMJE 2012/06605-9
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lilian Cuppari, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Lilian Cuppari, PhD Federal University of São Paulo
Principal Investigator: Christiane I Ramos Federal University of São Paulo
PRS Account Federal University of São Paulo
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP