None listed
Conditions
Brief summary
The primary purpose of the study is to reduce constipation in patients on renal dialysis in the Northland Districy Health Board using a wheat dextrin fibre supplement. The hypothesis is that the use of a wheat dextrin fibre supplement will improve bowel performance, reduce laxative use and improve quality of life in renal dialysis patients in the Northland District Health Board.
Interventions
Patients will be randomly assigned to receive a wheat dextrin fibre supplement or maltodextrin placebo for 4 weeks. After a 2 week washout period followed patients will then receive the opposite treatment to what they did in the first 4 weeks in a randomised crossover study. Patients will increase their supplement use in the first week up to a maximum of 15 grams. This will be done by being instructed to take 6 grams in days 1-3, 12 grams during days 4-6 and 15 grams on day 7. A maximum of 15 grams will then be taken for the next 3 weeks. The same will occur with the placebo. Both the wheat dextrin fibre supplement and the maltodextrin placebo disolve to be clear and tasteless in drinks and some foods. This is how the supplement will be instructed for patients to consume. All doses in the first week and following three weeks will be instructed to be taken as split doses over the day. For example, 15 grams is instructed to be taken as 9 grams in the morning and 6 grams in the evening. Supplement will be supplied to patients in blank 1L screw top containers with a scoop inside. One flat scoop will measure exactly 3 grams of fibre supplement. For example, when taking 15 grams per day patients are instructed to take 3 scoops in the morning and 2 scoops in the evening. Patients will be instructed to keep a record of how much supplement or placebo they take each day. They will also record their bowel habits and laxative use during the intervention period. Laxative use will be recorded to see if the dose taken can be reduced as the amount of supplement is increased. Phone calls will be made to monitor adherence. These will be scheduled weekly for each patient during each period - Observation, treatment and placebo.
Sponsors
Study design
Eligibility
Inclusion criteria
- Patient must be on peritoneal or haemodialysis - Patients must be taking laxatives
Exclusion criteria
- Those that do not take laxatives and that do not have constipation - Those with dementia - Those who have surgery scheduled in the next few months - Those using opioids - Those with coeliac disease - Those already using wheat dextrin fibre supplement