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Effect of melatonin enriched with L-Tryptophan and 5-Hydroxytryptophan on sleep parameters in children with
Francy Cruz-Sanabria1, Giovanni Cenerini2, Simone Bruno3
1Department of Developmental Neuroscience, IRCCS Stella Maris Foundation, Viale del Tirreno, 341/A/B/C, Calambrone, 56128, Pisa, Italy.
Insights
This pilot study explored melatonin with L-tryptophan (LT) or 5-Hydroxytryptophan (5HTP) for sleep in children with neurodevelopmental disorders (NDDs). The melatonin-5HTP combination showed a reduction in nocturnal motor activity in completers.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Neurodevelopmental Disorders
Background:
- Melatonin regulates sleep, but its combination with precursors like L-tryptophan (LT) and 5-Hydroxytryptophan (5HTP) for sleep disorders in children with neurodevelopmental disorders (NDDs) is understudied.
- This study addresses the limited evidence by comparing two such combinations.
Purpose of the Study:
- To compare the efficacy of melatonin combined with 5-Hydroxytryptophan (M-5HTP) versus melatonin combined with L-tryptophan (M-LT) in improving sleep parameters in children under five with NDDs.
Main Methods:
- A single-center, randomized pilot trial involved 26 children with NDDs.
- Participants received either M-5HTP (1mg Melatonin + 10mg 5HTP) or M-LT (1mg Melatonin + 20mg LT) nightly for at least four weeks.
- Sleep parameters were assessed using actigraphy before and after treatment.
Main Results:
- Only 13 children completed the study (9 in M-5HTP, 4 in M-LT).
- No significant differences were found between the M-5HTP and M-LT groups.
- The M-5HTP group showed a significant within-group reduction in the Sleep Movement Index (SMI) from baseline to follow-up (p=0.006).
Conclusions:
- The melatonin-5HTP combination demonstrated a potential to reduce nocturnal motor activity in children with NDDs who completed the study.
- Findings are hypothesis-generating due to the small sample size, high attrition, and limited statistical power, requiring cautious interpretation.
Introduction:
Melatonin plays a key role in sleep regulation. Combining melatonin with its precursors, L-tryptophan (LT) and 5-Hydroxytryptophan (5HTP), may influence sleep-related outcomes, but evidence in children with neurodevelopmental disorders (NDDs) is limited. This exploratory study compares the effects of melatonin combined with 5HTP (M-5HTP) and melatonin combined with LT (M-LT) on sleep disorders in children with NDDs.
Methods:
This single-center, randomized pilot comparative trial involved children under five years of age with NDDs free of sleep-inducing drugs. Baseline evaluations and actigraphy monitoring were performed. Children were randomly assigned to either M-5HTP (1 mg Melatonin +10 mg 5HTP) or M-LT (1 mg Melatonin +20 mg LT) treatment at 8 p.m. for at least four weeks. Post-treatment actigraphy monitoring assessed sleep parameters.
Results:
Of 51 screened children, 26 were enrolled and 13 completed the study (M-5HTP: 9, M-LT: 4). No statistically significant between-group differences in change scores were observed. Within-group analyses showed a significant reduction in the Sleep Movement Index (SMI) from baseline to follow-up in the M-5HTP group (T0: 6.55; T1: 1.25; p=0.006), whereas no significant changes were observed in the M-LT group.
Discussion:
In this exploratory pilot study, a within-group reduction in nocturnal motor activity was observed among M-5HTP completers. Given the small sample size, high attrition rate, and limited statistical power, these findings should be interpreted cautiously and considered hypothesis-generating.
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