Oral anabolic steroid increases muscle products in hemodialysis patients
| ISRCTN | ISRCTN41591818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41591818 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/04/2012
- Registration date
- 16/04/2012
- Last edited
- 18/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Protein-energy wasting is a common adverse consequence of end-stage kidney disease (ESKD) and is associated with impaired rehabilitation and increased morbidity (illness) and mortality (death). Individuals with ESKD are often poorly muscled. Moreover, low muscle mass in maintenance hemodialysis (MHD) patients is associated with increased mortality. Therapies designed to increase dialysis patients muscle mass and strength might therefore improve their exercise capacity and possibly their survival. Anabolic-androgenic steroid (AAS) therapy appears to be a promising alternative for treatment of muscle wasting in chronic illness. Anabolic steroids may increase lean body mass and muscle mass in adults without chronic kidney disease (CKD), as well as in MHD patients. Oxymetholone has the advantages that it can be given orally and exhibits higher anabolic activity and lower androgenic effects than testosterone. Several studies showed increased fat-free mass in patients taking oxymetholone, but no such studies have been conducted in people with CKD. The aim of this study is to examine whether orally administered oxymetholone improves protein-energy status and increases muscle mass in MHD patients.
Who can participate?
Patients aged 20 years or older, treated with MHD for at least 3 months.
What does the study involve?
Patients were randomly allocated to one of two treatment groups. One group received oxymetholone twice daily for 24 weeks. The other group received a placebo (dummy) drug in the same manner. All patients typically continued with their normal daily activities during both treatments and were monitored at home by a healthcare trainer. All patients kept a three-day food record and underwent dietary interviews by a registered dietitian. Body composition was assessed by dual energy absorptiometry on the day after a hemodialysis treatment, before and after the study period. Grip strength was also measured three times on each side, alternating between right and left hands using a handgrip dynamometer. Muscle biopsies of the right vastus lateralis muscle (on the side of the thigh) were performed at baseline and at the end of the study. Blood was collected immediately before a mid-week hemodialysis for biochemical measurements every four weeks and at the end of the trial. Adverse events that were or were not considered to be related to oxymetholone treatment were monitored every four weeks. Patients also underwent blood drawing for safety tests.
What are the possible benefits and risks of participating?
Oxymetholone treatment might improve muscle metabolism, muscle mass and handgrip strength in MHD patients. In addition, the oxymetholone treatment may improve physical functioning and decrease fat mass. Previous studies demonstrated that oxymetholone increases the incidence of some side effects (e.g., absence of menstruation, hair loss, excess hair growth in women, and deepening voice), and slightly increases liver dysfunction.
Where is the study run from?
The Hemodialysis Unit of The Kidney Foundation of Thailand.
When is the study starting and how long is it expected to run for?
The study ran from January 2007 until January 2008.
Who is funding the study?
The National Research Council of Thailand.
Who is the main contact?
Dr Ouppatham Supasyndh
Ouppatham@hotmail.com
Contact information
Scientific
Division of Nephrology
Phramongkutklao Hospital and College of Medicine
Bangkok
10400
Thailand
Study information
| Study design | Randomized double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Dr Ouppatham Supasyndh (Ouppatham@hotmail.com) to request a patient information sheet |
| Scientific title | Oral anabolic steroid increases muscle products in hemodialysis patients: a randomized controlled trial |
| Study hypothesis | Orally administered oxymetholone can improve protein-energy status and increase muscle mass in maintenance hemodialysis patients |
| Ethics approval(s) | Institute Review Board Ethics Committee, Phramongkutklao Hospital, Thailand, January 2007, ref: S005h/49 |
| Condition | Maintenance hemodialysis patients |
| Intervention | Eligible patients were randomly assigned into two groups. One group ingested oxymetholone, 50 mg twice daily for 24 weeks. The other group received a placebo in the same manner. All patients typically continued with their normal daily activities during both treatments and were monitored at home by a healthcare trainer. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxymetholone |
| Primary outcome measure | 1. Body composition was assessed by dual energy absorptiometry (DEXA; Hologic QDR-4500W, USA) on the day after a hemodialysis treatment, before and after the study period. 2. Grip strength was also measured three times on each side, alternating between right and left hands using a handgrip dynamometer 3. Muscle biopsies of the right vastus lateralis muscle were performed at baseline and at the end of the study. The muscle analyses include identification of mRNA levels by real-time polymerase chain reaction (PCR) amplification and protein concentrations of growth factors. Muscle fiber types were identified by nicotinamide dinucleotide diaphorase (NADH) staining and cross-sectional areas were examined by a renal pathologist. Blood was collected immediately before a mid-week hemodialysis for biochemical measurements, including testosterone, luteinizing hormone and cortisol at baseline, every 4 weeks and at the end of the trial. |
| Secondary outcome measures | Adverse events that were or were not considered to be related to oxymetholone treatment were monitored every 4 weeks. Patients also underwent blood drawing for safety tests that included complete blood counts, liver function tests and prostate-specific antigen. |
| Overall study start date | 01/01/2007 |
| Overall study end date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 48 |
| Participant inclusion criteria | 1. Aged 20 years or older 2. Treatment with maintenance hemodialysis (MHD) for at least 3 months 3. A single pool Kt/Vurea of 1.2 or greater per MHD treatment 4. No treatment with androgens or glucocorticoids within 6 months before starting the study |
| Participant exclusion criteria | 1. Patients with diabetes mellitus 2. Active malignancy 3. Severe heart, lung or liver disease, strokes, chronic infection (e.g., tuberculosis) within one year of starting the study 4. Any immunological or inflammatory disorders |
| Recruitment start date | 01/01/2007 |
| Recruitment end date | 01/01/2008 |
Locations
Countries of recruitment
- Thailand
Study participating centre
10400
Thailand
Sponsor information
Research council
196 Paholyotin Road
Chatuchak
Bangkok
10900
Thailand
| Website | http://www.nrct.go.th/index.php |
|---|---|
"ROR" |
https://ror.org/018wfhg78 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
