Melatonin for Post-Surgery Recovery in Teens with Scoliosis
(SurgerySMART Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByJennifer A Rabbitts, M.B.Ch.B.
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Prescription insomnia medication
Disqualifiers: Cognitive impairment, Severe chronic condition, others
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.
Will I have to stop taking my current medications?
If you are taking over-the-counter supplements or other sleep aids, you will need to stop them for 1 week before starting the study medication. The protocol does not specify about other medications, so it's best to discuss with the study team.
What data supports the effectiveness of the drug melatonin for post-surgery recovery in teens with scoliosis?
Research suggests that low melatonin levels may be linked to the development of scoliosis, and studies in animals have shown that melatonin supplementation can prevent scoliosis after certain surgeries. This implies that melatonin might help in managing scoliosis-related conditions, although direct evidence for post-surgery recovery in teens is not provided.
12345Is melatonin safe for humans?
The research does not provide specific safety data for melatonin in humans, but it has been used in animal studies without reported safety issues.
12346How does melatonin differ from other treatments for scoliosis recovery?
Melatonin is unique because it is a natural hormone that may help improve bone quality and reduce scoliotic curvature, especially in those with melatonin deficiency. Unlike other treatments, it works by potentially restoring melatonin levels, which could prevent scoliosis development and improve bone density.
12346Eligibility Criteria
This trial is for English-speaking teens aged 12-18 in California who are having spinal fusion surgery. They must have internet access and a smartphone, and their parents or guardians need to be involved. Teens with recent psychiatric admissions, very high BMI, untreated major medical conditions, or those on certain medications can't participate.Inclusion Criteria
Can read and understand English
I am between 12 and 18 years old.
I am scheduled for spinal fusion surgery for a specific condition.
+3 more
Exclusion Criteria
I won't stop taking supplements or sleep aids for a week before starting the study medication.
I have a serious long-term health condition that needs regular treatment.
Psychiatric admission in prior 30 days
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-treatment
Participants take melatonin or placebo and wear an actigraphy device before surgery
14 days
Daily check-ins (virtual)
Treatment
Participants continue taking melatonin or placebo and wear an actigraphy device after surgery
21 days
Daily check-ins (virtual)
Follow-up
Participants are monitored for sleep, pain, and quality of life outcomes
3 months
3 online surveys
Participant Groups
The study is testing if melatonin syrup helps teens recover after spinal fusion surgery by improving sleep quality. It will check how well the treatment works and whether it's something patients are okay with using both short-term and long-term.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 3mg fast-dissolve pill (containing melatonin)Experimental Treatment1 Intervention
Participants will take 3mg in fast-dissolve pill form containing the active ingredient melatonin, complete surveys, and wear an actigraphy device during the specified study period.
Group II: 3mg fast-dissolve pillPlacebo Group1 Intervention
Participants will take a placebo of 3mg fast-dissolve pill (without melatonin), complete surveys, and wear an actigraphy device during the specified study period.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Lucile Packard Children's HospitalPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Collaborator
References
Melatonin levels in idiopathic scoliosis. Diurnal and nocturnal serum melatonin levels in girls with adolescent idiopathic scoliosis. [2019]Matched pairs of adolescent girls were used to compare serum melatonin levels in adolescent patients and control subjects with idiopathic scoliosis during the day and in the middle of the night.
The role of melatonin in the pathogenesis of adolescent idiopathic scoliosis. [2019]A matched, case-control study comparing melatonin production in female patients with and without adolescent idiopathic scoliosis.
Evaluation of GPR50, hMel-1B, and ROR-alpha melatonin-related receptors and the etiology of adolescent idiopathic scoliosis. [2021]Adolescent idiopathic scoliosis (AIS) is the most common spinal deformity in children. Studies have shown low melatonin levels resulting from pinealectomy in chickens and mice result in the development scoliosis, whereas supplementation with melatonin after the pinealectomy prevented it. The mere characterization of low melatonin levels is not sufficient to explain the development of idiopathic scoliosis in primates and humans, but we hypothesize that a mutation in melatonin-related receptors may be involved with the development of scoliosis.
Total 24-hour melatonin secretion in adolescent idiopathic scoliosis. A case-control study. [2019]A case-control study of 24-hour urinary melatonin production in patients with adolescent idiopathic scoliosis.
[A preliminary study of melatonin signaling transduction pathway in BMSCs from adolescent idiopathic scoliosis patients]. [2018]To investigate the melatonin signaling transduction pathway in BMSCs from adolescent idiopathic scoliosis patients.
The effect of exogenous melatonin on reducing scoliotic curvature and improving bone quality in melatonin-deficient C57BL/6J mice. [2021]It is well-documented that melatonin deficiency has been linked to the etiopathogenesis of adolescent idiopathic scoliosis. In this study, we intended to apply melatonin in melatonin-deficient mice to ascertain whether melatonin could reduce the incidence/severity of scoliosis, and investigate the role of melatonin on bone mineral density in scoliosis. A total of 80 mice were divided into 4 groups: 20 quadrupedal mice and 20 bipedal mice served as controls; 20 quadrupedal and 20 bipedal mice received oral melatonin (8 mg/kg BW) daily. After 5th, 10th, 15th and 20th weeks of treatment, radiographs and in vivo micro-CT were used to determine the incidence of scoliosis and bone qualities, respectively. Upon sacrifice, the levels of melatonin were measured in each group. At 20th week, the occurrence of scoliosis was 80%, 30%, 22% and 5% in bipedal, quadrupedal, bipedal + melatonin and quadrupedal + melatonin group, respectively. The trabecular bone quality of the vertebral body was significantly ameliorated in the melatonin-treated bipedal models. Likewise, the number of osteoclasts was significantly less in those treated with melatonin. Our results indicated that melatonin deficiency may be crucial for scoliotic development, and restoration of melatonin levels can prevent scoliotic development with the improvement in bone density.