None listed
Conditions
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.
Interventions
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed