Oral anabolic steroid increases muscle products in hemodialysis patients

Completed

Conditions: Maintenance hemodialysis patients
Urological and Genital Diseases

Registration Number: ISRCTN41591818

Lead Sponsor: The National Research Council of Thailand (Thailand)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>2. Grip strength was also measured three times on each side, alternating between right and left hands using a handgrip dynamometer<br>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

Name	Time	Method
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.