University of Dundee and NHS Tayside to investigate the role of Sodium bicarbonate in improving the Quality of Life in Chronic Kidney Disease?

22-3-2013 — /europawire.eu/ — Researchers from the University of Dundee and NHS Tayside are to lead a £1.2million UK-wide project, funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme, to investigate the role of Sodium bicarbonate in improving physical function and quality of life for older people with advanced Chronic Kidney Disease (CKD).

Between 20-25% of people over the age of 65 have some degree of kidney disease and often have high levels of acid in their blood (acidosis). This increase in acid may cause muscle weakness and tiredness, as well as further problems with blood vessels, kidneys and bone health.

“Acid in the blood is commonly treated with Sodium bicarbonate, a substance found in baking powder. However, there is no conclusive evidence of its effectiveness or universal prescribing guidelines. If found to be effective Sodium bicarbonate could be a safe and inexpensive treatment,” said Dr Miles Witham, Senior Clinical Lecturer in Ageing and Health at the University of Dundee, who is leading the study.

“This study aims to provide evidence to help doctors and patients make an informed decision about treatment.”

The BiCARB study involves colleagues in the University of Aberdeen, University of Kent, and Kings College London.

It will be carried out with the collaboration of NHS colleagues in NHS Tayside, NHS Grampian, East Kent Hospitals University NHS Foundation Trust, Guy’s and St Thomas’ NHS Foundation Trust, Salford Royal NHS Foundation Trust and Sheffield Teaching Hospitals NHS Foundation Trust.

The study will recruit 380 patients with CKD from six NHS trusts throughout the UK. Each participant will be allocated at random to receive either Sodium bicarbonate or placebo. Neither the patient nor the study team know which tablets the patient will be taking.

Patients will be in the trial for 2 years and will be randomly allocated to take either Sodium bicarbonate or placebo (dummy) tablets three times a day. The patients will be assessed before they start the tablets and regularly during the 2 years they are in the trial. The results of their assessments will be examined to compare whether the patients taking the Sodium bicarbonate tablets improve their physical function and quality of life more than the patients taking the placebo tablets.

Mr Alex Stephen, a transplant patient in Dundee, has been appointed as the Patient Representative. “A lay summary will be produced and be available via newsletters and the website so that patients will have a better understanding of progress throughout the study period,” said Mr Stephen.

The study will measure physical fitness and quality of life as well as bone health, blood vessel health and will also test whether sodium bicarbonate slows down the progression of kidney disease.

NOTES FOR EDITORS

1. The National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme funds research about the effectiveness, costs, and broader impact of health technologies for those who use, manage and provide care in the NHS. It is the largest NIHR programme and publishes the results of its research in the Health Technology Assessment journal, with over 600 issues published to date. The journal’s 2011 Impact Factor (4.255) ranked it in the top 10% of medical and health-related journals. All issues are available for download, free of charge, from the website. The HTA Programme is funded by the NIHR, with contributions from the CSO in Scotland, NISCHR in Wales, and the HSC R&D Division, Public Health Agency in Northern Ireland. www.hta.ac.uk.
2. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).

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