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NCT01607879 · ClinicalTrials.gov registry record · Phase 2

Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation

A Phase 2 study, sponsored by Medical College of Wisconsin.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT01607879: Completed Phase 2 study, sponsored by Medical College of Wisconsin.

NCT01607879 is a Phase 2 study that has completed, run by Medical College of Wisconsin. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01607879, a Phase 2 study, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

Primary Outcome

This measure will be the change of lean body mass from baseline reported in kilograms.

Interventions

  • DRUG Standard of care ADT + (HMB + arginine + glutamine)
  • OTHER Standard of care ADT

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-03
Est. Completion 2021-02-16
Phase Phase 2
Medical College of Wisconsin

447 total trials

What the finished NCT01607879 record still lists

NCT01607879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of care ADT + (HMB + arginine + glutamine) is the first listed.

NCT01607879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01607879 about?

NCT01607879 is a clinical study titled "Use of β-hydroxy-β-methylbutyrate to Counteract Muscle Loss in Men With Prostate Cancer on Androgen Ablation". This is a study of HMB plus amino acids in older men with prostate cancer starting androgen deprivation therapy (ADT). The investigators hypothesize that the use of this nutritional supplementation will decrease the loss of muscle mass and strength that occurs when men start ADT.

What is the current status of trial NCT01607879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2014-03. Estimated completion is 2021-02-16.

What interventions are being tested in trial NCT01607879?

The interventions under investigation include: Standard of care ADT + (HMB + arginine + glutamine) (DRUG), Standard of care ADT (OTHER).

Who is sponsoring clinical trial NCT01607879?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01607879's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01607879, the US trial registry maintained by the National Library of Medicine. NCT01607879 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.