Oral anabolic steroid increases muscle products in hemodialysis patients

Oral anabolic steroid increases muscle products in hemodialysis patients: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41591818

Enrollment

Registered

2012-04-16

Start date

2007-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maintenance hemodialysis patients Urological and Genital Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026