✓ Translated by DotMD AI Clinical Council Source: The Journal of clinical endocrinology and metabolism • Randomized Controlled Trial
Verify Primary Source: NIH PubMed PMID #11600532 ↗

Randomized Controlled Trial: Melatonin treatment for age-related insomnia (N = 15)

Original Paper Title: “Melatonin treatment for age-related insomnia”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 15
Evidence Classification
Randomized Controlled Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The pharmacologic dose (3.0 mg), like the lowest dose (0.1 mg), also improved sleep; however, it induced hypothermia and caused plasma melatonin to remain elevated into the daylight hours. Although control subjects, like insomniacs, had low melatonin levels, their sleep was unaffected by any melatonin dose.
  • Study Design & Sample: Randomized Controlled Trial published in The Journal of clinical endocrinology and metabolism (N = 15 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in The Journal of clinical endocrinology and metabolism (2001), this randomized controlled trial evaluating 15 human participants investigated: Older people typically exhibit poor sleep efficiency and reduced nocturnal plasma melatonin levels. Key clinical takeaway: The pharmacologic dose (3.0 mg), like the lowest dose (0.1 mg), also improved sleep; however, it induced hypothermia and caused plasma melatonin to remain elevated into the daylight hours. Although control subjects, like insomniacs, had low melatonin levels, their sleep was unaffected by any melatonin dose.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (The Journal of clinical endocrinology and metabolism, 2001-10-15; N = 15; Rigor 88/100): The pharmacologic dose (3.0 mg), like the lowest dose (0.1 mg), also improved sleep; however, it induced hypothermia and caused plasma melatonin to remain elevated into the daylight hours. Although control subjects, like insomniacs, had low melatonin levels, their sleep was unaffected by any melatonin dose.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Randomized Controlled Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Condition: circadian-rhythm-sleep-disorder-jet-lag-type → Condition: circadian-rhythm-sleep-disorder-shift-work-type →
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