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Sleep difficulties in children with autism spectrum disorders (ASD) are common reasons why parents seek medical intervention for their children. Identifying a safe and effective pharmacologic agent that promotes sleep in ASD would favorably impact the lives of these children and their families. In this study we plan to determine the dose-response, tolerability and any adverse effects of supplemental melatonin in 30 children with ASD.The melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. After a 3 week baseline period, the child will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling asleep within 30 minutes of bedtime at least 5/7 nights per week. No child will take more than 9 mg of supplemental melatonin.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
supplemental liquid melatonin, flavored liquid or liquid supplemental melatonin
Vanderbilt Medical Center
Published on BioPortfolio: 2014-08-27T03:21:12-0400
The aim of this study is to investigate the effects of supplemental oxygen on blood oxygenation at rest in Patients with severe to very severe COPD comparing the portable oxygen concentrat...
Breast milk is readily accepted as the ideal source of nutrition for almost all infants, including premature or very low birth weight infants. However, these high-risk infants require the ...
Melatonin (MLT) is a bioactive compound in red wine. The investigators will investigate the serum and salivary concentrations and antioxidant power of MLT after the intake of a glass of re...
The primary focus of this five-year study will be to optimize the melatonin dosing regimen for synchronizing the body clocks of blind children to the 24-hour day.
This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with fo...
Circulating melatonin is a good candidate biomarker for studies of circadian rhythms and circadian disruption. However, epidemiologic studies on circulating melatonin are limited because melatonin is ...
The Na-K alloy is a liquid at 25 °C over a large compositional range. The liquid alloy is also immiscible in the organic-liquid electrolytes of an alkali-ion rechargeable battery, providing dendrite-...
Melatonin use in clinical psychiatry is currently rife, and the trend of utilization is on the rise. Efficacy coupled with safety and lack of abuse potential render melatonin an attractive therapeutic...
We investigated the atomic structure of liquid Rb along an isothermal path at 573 K, up to 23 GPa, by x-ray diffraction measurements. By rising pressure, we observed a liquid-liquid transformation bet...
Melatonin, a powerful antioxidant, participates in the regulation of important physiological and pathological processes. We investigated the actions of melatonin on neuronal excitability of intact dor...
Food and dietary formulations including elemental (chemically defined formula) diets, synthetic and semisynthetic diets, space diets, weight-reduction formulas, tube-feeding diets, complete liquid diets, and supplemental liquid and solid diets.
The removal of a soluble component from a liquid mixture by contact with a second liquid, immiscible with the carrier liquid, in which the component is preferentially soluble. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)
A biogenic amine that is found in animals and plants. In mammals, melatonin is produced by the PINEAL GLAND. Its secretion increases in darkness and decreases during exposure to light. Melatonin is implicated in the regulation of SLEEP, mood, and REPRODUCTION. Melatonin is also an effective antioxidant.
Miniaturized methods of liquid-liquid extraction.
A family of G-protein-coupled receptors that are specific for and mediate the effects of MELATONIN. Activation of melatonin receptors has been associated with decreased intracellular CYCLIC AMP and increased hydrolysis of PHOSPHOINOSITIDES.
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
Autism affects half a million people in the UK. Men are affected more than women. People with autism have said that the world, to them, is a mass of people, places and events which they struggle to make sense of, and which can cause them considerable a...
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...