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Trial registered on ANZCTR


Registration number
ACTRN12623000972628
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
6/09/2023
Date last updated
6/09/2023
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of zinc supplementation on anorexia in chronic kidney disease
Scientific title
The impact of zinc supplementation on anorexia in people with kidney failure receiving conservative kidney management: A pilot study
Secondary ID [1] 310202 0
None
Universal Trial Number (UTN)
Trial acronym
SEISMIC-Zinc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia 331077 0
Condition category
Condition code
Renal and Urogenital 327866 327866 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be treated with either 342mg oral Zinc Gluconate daily (equivalent to 45mg elemental zinc) or matched placebo to be taken orally once daily.
Duration of administration: 3-months
Mode of administration: Oral capsule
4-weekly follow-up contacts will be carried out to promote adherence to the supplements and to monitor for side effects. Participants will be required to return any unused investigational product for remaining content to be counted to allow assessment of adherence.
Intervention code [1] 326743 0
Treatment: Drugs
Comparator / control treatment
Matched placebo containing microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 335710 0
Change in self-reported anorexia from baseline to 3-months. Anorexia will be measured using the Council for Nutrition Appetite Questionnaire.
Timepoint [1] 335710 0
Anorexia will be measured at baseline, 3 months and 4 months post baseline.
Secondary outcome [1] 425251 0
Self-reported symptom burden, including gastrointestinal symptoms will be assessed using a 10-point scale from “none” to “worst possible”
Timepoint [1] 425251 0
Symptom burden will be assessed at baseline, 3 months and 4 months post baseline.
Secondary outcome [2] 425661 0
Plasma zinc levels
Timepoint [2] 425661 0
Plasma zinc levels will be measured at baseline and 3-months post-baseline
Secondary outcome [3] 425662 0
Serum leptin
Timepoint [3] 425662 0
Serum leptin levels will be measured at baseline and 3-months post-baseline
Secondary outcome [4] 425663 0
Serum High sensitivity C-reactive protein (hsCRP)
Timepoint [4] 425663 0
Serum hsCRP levels will be measured at baseline and 3-months post-baseline
Secondary outcome [5] 425664 0
Change in total calorie intake. Dietary intake will be assessed using the 24 hour pass methodology, conducted by a dietitian.
Timepoint [5] 425664 0
Change in total calorie intake from baseline to 3-months.
Secondary outcome [6] 425665 0
Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment (PG-SGA).
Timepoint [6] 425665 0
Nutritional status will be assessed at baseline and 3-months post-baseline
Secondary outcome [7] 426169 0
Change in dietary protein intake. Dietary intake will be assessed using the 24 hour pass methodology, conducted by a dietitian.
Timepoint [7] 426169 0
change in intake from baseline to 3 months
Secondary outcome [8] 426170 0
change in dietary zinc intake. Dietary intake will be assessed using the 24 hour pass methodology, conducted by a dietitian.
Timepoint [8] 426170 0
Change in dietary zinc intake from baseline to 3 months.

Eligibility
Key inclusion criteria
(1) Aged 18 years and over,
(2) Established chronic kidney disease (review of eGFR over the previous 12 months),
(3) eGFR =<20ml/min/1.73m2 for at least 3 months, and
(4) Self-reported anorexia (poor appetite) for =/>2 consecutive weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Be receiving Kidney replacement therapy (hemodialysis, peritoneal dialysis, kidney transplant),
(2) Planning to commence KRT within the next 4 months,
(3) Significant acute nutritional compromise that requires immediate nutritional intervention
(e.g., greater than or equal to 10% unintentional weight loss in the previous month and/or nutritional intake meeting less than 50% of estimated energy requirements),
(4) Confirmed or suspected non-kidney disease related cause of anorexia (defined by cytotoxic chemotherapy or head or neck radiotherapy within 3 months, or in the opinion of the investigator),
(5) Known or suspected eating disorder,
(6) Active malignancy, and
(7) Life expectancy less than 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
22/12/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25351 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 41061 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 314370 0
Charities/Societies/Foundations
Name [1] 314370 0
St. George and Sutherland Medical Research Foundation
Country [1] 314370 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials CentreUniversity of SydneyMedical Foundation Building92 – 94 Parramatta Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 316320 0
None
Name [1] 316320 0
Address [1] 316320 0
Country [1] 316320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313463 0
South Eastern Sydney Local Health District Human Research Ethics Committee (SESLHD HREC)
Ethics committee address [1] 313463 0
District Executive Unit, Level 4 The Sutherland Hospital & Community Health Service Cnr The Kingsway & Kareena Road Caringbah NSW 2229
Ethics committee country [1] 313463 0
Australia
Date submitted for ethics approval [1] 313463 0
Approval date [1] 313463 0
22/06/2023
Ethics approval number [1] 313463 0

Summary
Brief summary
People with kidney failure receiving conservative kidney management (CKM) (i.e., non-dialysis) suffer a high symptom burden, malnutrition, morbidity and mortality. Anorexia is experienced by approximately 50% of this population and is associated with reduced quality of life, reduced dietary intake, anaemia, increased rates malnutrition, inflammation and increased rates of hospitalisation.

Zinc is an important trace mineral and antioxidant, with deficiencies associated with anorexia, hypogeusia, anaemia, impaired immune function, delayed wound healing, weight loss and inflammation. There are several potential zinc-induced mechanisms that may impact on anorexia in advanced CKD. Trials evaluating the impact of a cheap and accessible intervention such as zinc supplementation on these symptoms addresses a clear unmet need of importance to patients.

Research Methodology:
This will be a 3-month, double-blind, placebo-controlled, pilot randomised trial of zinc supplementation. This pilot is a component of a larger program of work of Systematic Evaluation of Interventions for Symptom Management In Chronic Kidney Disease (SEISMIC).

The study consists of a 12-week treatment period:
(1) 342mg Zinc Gluconate to be taken orally once daily, or
(2) Matched placebo to be taken orally once daily

Participants will be recruited through the Kidney Supportive Care clinic at St. George Hospital

Aim: The primary aim of this study is to determine the impact of zinc supplementation to improve anorexia in people with kidney failure receiving conservative kidney management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128250 0
Dr Jessica Dawson
Address 128250 0
NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 92 – 94 Parramatta Road, Camperdown NSW 2050
Country 128250 0
Australia
Phone 128250 0
+61 428 779 640
Fax 128250 0
Email 128250 0
jessica.dawson@sydney.edu.au
Contact person for public queries
Name 128251 0
Dr Jessica Dawson
Address 128251 0
NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 92 – 94 Parramatta Road, Camperdown NSW 2050
Country 128251 0
Australia
Phone 128251 0
+61 428 779 640
Fax 128251 0
Email 128251 0
jessica.dawson@sydney.edu.au
Contact person for scientific queries
Name 128252 0
Dr Jessica Dawson
Address 128252 0
NHMRC Clinical Trials Centre, University of Sydney, Medical Foundation Building, 92 – 94 Parramatta Road, Camperdown NSW 2050
Country 128252 0
Australia
Phone 128252 0
+61 428 779 640
Fax 128252 0
Email 128252 0
jessica.dawson@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.