Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02130089




Registration number
NCT02130089
Ethics application status
Date submitted
28/04/2014
Date registered
5/05/2014
Date last updated
27/01/2016

Titles & IDs
Public title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Scientific title
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?
Secondary ID [1] 0 0
13-186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease Requiring Hemodialysis 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other: All patients - Intensive tailored education
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Percent Interdialytic Weight Gain
Timepoint [1] 0 0
monthly for 7 months
Secondary outcome [1] 0 0
Thirst Intensity
Timepoint [1] 0 0
monthly for 7 months
Secondary outcome [2] 0 0
Sodium and Fluid Knowledge
Timepoint [2] 0 0
Monthly for 4 months

Eligibility
Key inclusion criteria
* Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
* Able to sign the locally approved informed consent
* Willing to receive dietitian education on sodium and fluid control during normal dialysis time
* Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* On hospice or international equivalent
* Receiving corticosteroid treatment
* Less than 18 years old
* On interdialytic parenteral nutrition
* Transfer to another facility expected within 3 months
* Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Academy of Nutrition and Dietetics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra McLellan
Address 0 0
Auckland Board of Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02130089