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NCT02631148 · ClinicalTrials.gov registry record · Phase 2
Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT02631148: Clinical Trial Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT02631148 is a Phase 2 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02631148, a Phase 2 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatonin supplementation in the community is a feasible intervention with a beneficial effect on the following chronic kidney disease (CKD) risk factors: systemic and renal specific renin-aldosterone-angiotensin system (RAAS) activation (systemic plasma renin activity, plasma angiotensin II levels, 24-hour urine aldosterone excretion, and renal plasma flow response to captopril); nocturnal blood pressure measured by 24-hour ambulatory blood pressure monitor; central blood pressure measured by pulse wave analysis; and glucose metabolism measured by Minimal Model assessment of insulin resistance and β-cell response to a mixed meal protocol.
Primary Outcome
renal specific RAAS activity will be assessed via para-aminohippurate (PAH) renal plasma flow testing with captopril
Interventions
- DRUG Placebo
- DRUG Melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 2 |
Why NCT02631148 stopped before completion
NCT02631148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02631148 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02631148 about?
NCT02631148 is a clinical study titled "Effects of Melatonin Supplementation on Renal Physiology in a Habitual Sleep Restricted Population.". In a 6 week pilot study, 20 individuals with habitual sleep restriction will all be asked to extend their nightly sleep by 1 hour, and will then be randomized 1:1 to nightly controlled-release oral melatonin (2mg) or placebo. The investigators will assess whether sleep extension and nightly melatoni...
What is the current status of trial NCT02631148?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2016-01. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT02631148?
The interventions under investigation include: Placebo (DRUG), Melatonin (DRUG).
Who is sponsoring clinical trial NCT02631148?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02631148's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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