Nandrolone (Deca Durabolin) Studies in Humans

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A Randomized, Placebo-Controlled Trial of Nandrolone Decanoate in Human Immunodeficiency Virus-Infected Men with Mild to Moderate Weight Loss with Recombinant Human Growth Hormone as Active Reference Treatment

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by Storer, Thomas W; Woodhouse, Linda J; Sattler, Fred; See more...


The Journal of Clinical Endocrinology & Metabolism, 08/2005, Volume 90, Issue 8

We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH. In this placebo-controlled, randomized, 12-wk trial, placebo and nandrolone (150 mg im biweekly) were administered double blind, and rhGH (6 mg sc daily) was administered in an open-label manner. Participants were HIV-infected men with 5-15% weight loss over 6 months and on stable antiretroviral therapy for more than 12 wk. Lean body mass (LBM), muscle performance, physical function, endurance, hormone levels, insulin sensitivity, sexual function, quality of life, and appetite were assessed at baseline and after 12 wk.

Nandrolone Deca Durabolin Studies in Humans.png



Nandrolone administration was associated with a greater increase in LBM (+1.6 +/- 0.3 kg) by dual-energy x-ray absorptiometry scan than placebo (+0.4 +/- 0.3 kg; P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 +/- 0.3 kg). Nandrolone administration was also associated with significantly greater gains in fat-free mass (+1.6 +/- 0.3 kg), body cell mass (+1.0 +/- 0.2 kg), and intracellular water (+0.9 +/- 0.2 kg) than placebo; these changes in the nandrolone group were not significantly different from the rhGH group. rhGH administration was associated with greater loss of whole body fat mass and higher frequency of drug-related adverse effects and treatment discontinuations than nandrolone and placebo and a greater increase in extracellular water than nandrolone. Nandrolone treatment was associated with greater improvements in perception of health than rhGH and sexual function than placebo. The cachexia/anorexia scores, health care resource use, and insulin sensitivity did not significantly change. We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.
 
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Nandrolone is an anabolic steroid, the main uses of which have been in osteoporosis in postmenopausal women, and in the treatment of anemia due to chronic renal failure, cytotoxic drug therapy or aplastic anemia. It is no longer recommended for the treatment of osteoporosis. Nandrolone has androgenic and anabolic actions and is administered by intramuscular injection in an oily base.

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Anabolic Effects of Nandrolone Decanoate in Patients Receiving Dialysis
A Randomized Controlled Trial


Kirsten L. Johansen, MD; Kathleen Mulligan, PhD; Morris Schambelan, MD
JAMA. 1999;281(14):1275-1281. doi:10.1001/jama.281.14.1275


Abstract
Context Patients receiving dialysis commonly experience malnutrition, reduced muscle mass (sarcopenia), and fatigue for which no effective treatment has been identified. Anabolic steroids are known to increase muscle mass and strength in healthy individuals, but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated.

Objective To assess the effects of an anabolic steroid, nandrolone decanoate, on lean body mass (LBM), functional status, and quality of life in dialysis patients.

Design Randomized, double-blind, placebo-controlled trial conducted between April 1996 and July 1997.

Setting Hospital-based outpatient dialysis unit.

Patients Twenty-nine patients undergoing dialysis for at least 3 months.

Intervention Nandrolone decanoate, 100 mg (n = 14), or placebo (n = 15) by intramuscular injection once a week for 6 months.

Main Outcome Measures Weight, LBM, fatigue, grip strength, walking and stair-climbing times, and treadmill performance after 3 and 6 months of treatment.

Results Lean body mass increased significantly in patients given nandrolone compared with patients given placebo (mean change [SD], +4.5 [2.3] kg; P<.001 compared with baseline). This effect was significantly greater than the change in LBM in the placebo group (mean change [SD], +1.9 [1.6] kg; P = .003 compared with baseline; P = .005 compared with nandrolone group). Serum creatinine levels increased in the nandrolone group (+168 [203] mmol/L [1.9 {2.3} mg/dL]; P = .02) but not in the placebo group (−4.0 [177] mmol/L [0.04 {2.0} mg/dL]; P = .95), suggesting an increase in muscle mass. Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the nandrolone group, while those in the placebo group increased from 38.7 to 42.1 seconds (P = .05). Peak oxygen consumption increased in the individuals in the nandrolone group who performed treadmill tests, but not to a statistically significant degree. Grip strength did not change in either group.

Conclusions Treatment with nandrolone for 6 months resulted in a significant increase in LBM associated with functional improvement in patients undergoing dialysis.

In the United States, the average life span of a patient entering a long-term dialysis program is less than half that of an age-matched control not receiving dialysis.1 Although the cause of this discrepancy is probably multifactorial, both malnutrition and reduced muscle mass are common in dialysis patients2-6 and have been shown to correlate with increased mortality.3,5-8 Therapies designed to improve the nutritional status of dialysis patients might therefore be expected to improve outcome. Anabolic agents, such as human growth hormone, can improve nitrogen balance in patients undergoing dialysis and in other catabolic states.9-14 Human growth hormone reduces urea generation and protein catabolic rate in long-term hemodialysis patients in short-term studies.12,13 However, human growth hormone can exacerbate hyperglycemia in patients with diabetes, who represent a large percentage of malnourished hemodialysis patients. Moreover, human growth hormone is expensive and may have limited potential as a long-term treatment.

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Great summary of nandrolone studies in humans

Nandrolone Related Published Studies


Well-designed clinical trials related to Nandrolone
Therapeutic effects of nandrolone and testosterone in adult male HIV patients with AIDS wasting syndrome (AWS): a randomized, double-blind, placebo-controlled trial. [2010.07]

Influence of delivery mode on the urinary excretion of nandrolone metabolites. [2010.04]

Nandrolone excretion in sedentary vs physically trained young women. [2010.02]

Beneficial effects of nandrolone decanoate in wasting associated with HIV. [2009.05]

Effects of testosterone and nandrolone on cardiac function: a randomized, placebo-controlled study. [2007.02]

Effects of resistance exercise training and nandrolone decanoate on body composition and muscle function among patients who receive hemodialysis: A randomized, controlled trial.[2006.08]

Effects of nandrolone decanoate compared with placebo or testosterone on HIV-associated wasting. [2006.04]

Double-blind, placebo-controlled study of the efficacy of nandrolone laurate in the treatment of dobermanns with subclinical hepatitis. [2005.09.10]

A randomized, placebo-controlled trial of nandrolone decanoate in human immunodeficiency virus-infected men with mild to moderate weight loss with recombinant human growth hormone as active reference treatment. [2005.08]

The effect of nandrolone decanoate on bone mineral density, muscle mass, and hemoglobin levels in elderly women with osteoporosis: a double-blind, randomized, placebo-controlled clinical trial. [2005.05]

Effects of high-intensity exercises on 13C-nandrolone excretion in trained athletes. [2005.05]

Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.[2005.03.14]

Parenteral iron therapy in treatment of anemia in end-stage renal disease patients: a comparative study between iron saccharate and gluconate. [2005]

Effects of protein-rich supplementation and nandrolone in lean elderly women with femoral neck fractures. [2004.08]

Body mass reduction markedly improves muscle performance and body composition in obese females aged 61-75 years: comparison between the effects exerted by energy-restricted diet plus moderate aerobic-strength training alone or associated with rGH or nandrolone undecanoate. [2004.04]

Metabolic effects of nandrolone decanoate and resistance training in men with HIV. [2002.12]

A comparison of megestrol acetate, nandrolone decanoate and dietary counselling for HIV associated weight loss. [2001.08]

Body composition and anthropometry in bodybuilders: regional changes due to nandrolone decanoate administration. [2001.04]

Trace contamination of over-the-counter androstenedione and positive urine test results for a nandrolone metabolite. [2000.11.22]

Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. [1999.04.14]

Effects of pharmacological doses of nandrolone decanoate and progressive resistance training in immunodeficient patients infected with human immunodeficiency virus. [1999.04]

Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss. [1999.02.01]

The use of an anabolic steroid (nandrolone decanoate) to improve nutritional status after esophageal resection for carcinoma. [1999]

Nandrolone decanoate is a good alternative for the treatment of anemia in elderly male patients on hemodialysis. [1999]

Nandrolone decanoate for men with osteoporosis. [1998.03]

Pharmacokinetics and pharmacodynamics of nandrolone esters in oil vehicle: effects of ester, injection site and injection volume. [1997.04]

Nandrolone decanoate and intranasal calcitonin as therapy in established osteoporosis.[1997]

Nandrolone, a 19-nortestosterone, enhances insulin-independent glucose uptake in normal men. [1996.04]

Effect of nandrolone decanoate and 1-alpha-hydroxy-calciferol on patients with vertebral osteoporotic collapse. A double-blind clinical trial. [1994.12]

Course of bone mass during and after hormonal replacement therapy with and without addition of nandrolone decanoate. [1994.02]

Effects of nandrolone decanoate on bone mass in established osteoporosis. [1993.11]

Can nandrolone add to the effect of hormonal replacement therapy in postmenopausal osteoporosis? [1992.09]

A controlled trial of recombinant human erythropoietin and nandrolone decanoate in the treatment of anemia in patients on chronic hemodialysis. [1992.05]

The prevention of corticosteroid-induced osteoporosis with nandrolone decanoate. [1991.10]

Effects of nandrolone decanoate therapy on bone mass and calcium metabolism in women with established post-menopausal osteoporosis: a double-blind placebo-controlled study.[1989.09]

Nandrolone decanoate (deca-durabolin) in primary Sjogren's syndrome: a double blind pilot study. [1988.01]

Hormonal treatment of advanced breast cancer. A randomized trial of tamoxifen versus nandrolone decanoate. [1987.11.15]
 
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