Public trial
RBR-2nw7kjm Melatonin as a therapeutic tlternative in the treatment of sickle cell disease: a clinical trial
Date of registration: 09/15/2026 (mm/dd/yyyy)Last approval date : 09/15/2026 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
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Efficacy and safety of Melatonin and Cannabidiol use in Sickle cell disease
pt-br
Eficácia e segurança do uso de Melatonina e Canabidiol na doença falciforme
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Efficacy and safety of Melatonin and Cannabidiol use in Sickle cell disease
Trial identification
- UTN code: U1111-1333-1178
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Public title:
en
Melatonin as a therapeutic tlternative in the treatment of sickle cell disease: a clinical trial
pt-br
Melatonina como alternativa terapêutica no tratamento da doença falciforme: um ensaio clínico
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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77409424.9.0000.8060
Issuing authority: Plataforma Brasil
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6.679.213
Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal do Oeste da Bahia
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77409424.9.0000.8060
Sponsors
- Primary sponsor: Universidade Federal do Oeste da Bahia
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Secondary sponsor:
- Institution: Universidade Federal do Oeste da Bahia
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Supporting source:
- Institution: Fundação Maria Emília
Health conditions
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Health conditions:
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Sickle cell disease
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Doença Falciforme
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General descriptors for health conditions:
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D58.2 hemoglobinopathy
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D58.2 hemoglobinopatia
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Specific descriptors:
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D57 Sickle cell disease
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D57 Doença falciforme
Interventions
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Interventions:
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This is a randomized, controlled, two-arm, double-blind clinical trial with a crossover design. The experimental group will consist of 20 patients, regardless of sex, aged 18 to 50 years, with a molecularly confirmed diagnosis of sickle cell disease, receiving 60 mg of melatonin, to be taken once daily, 1 hour before bedtime. The control group will consist of 20 patients, regardless of sex, aged 18–50 years, with a molecularly confirmed diagnosis of sickle cell disease, receiving a placebo, to be taken once daily, 1 hour before bedtime. Both capsules, containing either placebo or melatonin, will be formulated to have the same weight, odor, and taste. Patients will be followed for 180 days, with an initial blood sample collection corresponding to time 0, followed by two additional blood sample collections at time 1 and time 2. After a 30 day washout period, the groups will undergo a crossover, switching interventions
pt-br
Trata-se de um estudo clínico randomizado controlado de dois braços, duplo-cego, com delineamento crossover. Grupo experimental: 20 pacientes, independente do sexo, de 18 a 50 anos, com diagnóstico molecular confirmado para doença falciforme recebendo melatonina 60 mg, que deverá ser ingerida uma vez ao dia, 1 hora antes de dormir. Grupo controle: 20 pacientes, independente do sexo, de 18-50 anos, com diagnóstico molecular confirmado para doença falciforme recebendo placebo que deverá ser ingerido uma vez ao dia, 1 hora antes de dormir. Ambas as cápsulas, contendo placebo e contendo melatonina, serão formuladas para ter o mesmo peso, cheiro e sabor. Os pacientes serão acompanhados durante 180 dias, com uma coleta de sangue inicial, correspondente ao tempo 0, além de outras duas coletas, tempo 1 e tempo 2. Após período de washout de 30 dias, os grupos realizarão crossover, invertendo as intervenções
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Descriptors:
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D03.633.100.473.914.481 Melatonin
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D03.633.100.473.914.481 Melatonina
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 02/01/2026 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 40 - 18 Y 45 Y -
Inclusion criteria:
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Individuals with sickle cell disease, genotype SS or SC, with a previously confirmed molecular diagnosis, aged 18 to 50 years, of both sexes, receiving follow-up care in the Sickle Cell Disease Care Program, based at the Leonídia Ayres Municipal Health Center, Barreiras, Bahia, Brazil
pt-br
Pessoas com doença falciforme, genótipo SS e SC, com diagnóstico molecular prévio, entre 18 a 50 anos, do sexo masculino e feminino, em acompanhamento no programa de atenção à doença falciforme, sediado no centro de saúde municipal Leonídia Ayres, em Barreiras, Bahia, Brasil
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Exclusion criteria:
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Patients with sickle cell disease who do not have the SS or SC genotypes; patients whose age falls outside the predefined age range; patients on the waiting list for bone marrow transplantation; patients who do not receive regular follow-up through the Sickle Cell Disease Care Program, based at the Leonídia Ayres Municipal Health Center, in Barreiras, Bahia, Brazil; patients receiving regular blood transfusions; pregnant women; patients with known resistance to or adverse reactions to melatonin; and patients using medications or substances known to have significant interactions with melatonin
pt-br
Pacientes com doença falciforme que não apresentem os genótipos SS ou SC; pacientes cuja idade esteja fora da faixa etária previamente estabelecida; pacientes em lista de espera para transplante de medula óssea; pacientes que não realizem acompanhamento regular no Programa de Atenção à Pessoa com Doença Falciforme, sediado no Centro Municipal de Saúde Leonídia Ayres de Almeida, em Barreiras, Bahia, Brasil; pacientes submetidos a regime regular de transfusão sanguínea; gestantes; pacientes com resistência conhecida ou reações adversas relacionadas ao uso de melatonina; e pacientes que utilizem medicamentos ou substâncias que apresentem interações significativas com a melatonina
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Cross-over 2 Double-blind Randomized-controlled 2
Outcomes
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Primary outcomes:
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It’s expected to find changes in oxidative stress and inflammatory biomarkers
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Espera-se observar mudanças nos biomarcadores inflamatórios e de estresse oxidativo
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Secondary outcomes:
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It’s expected to find changes in sleep quality, fatigue, daytime sleepiness, depressive symptoms, and clinical outcomes related to sickle cell disease, as well as safety and tolerability of melatonin.
pt-br
Espra-se observar changes in sleep quality, fatigue, daytime sleepiness, depressive symptoms, and clinical outcomes related to sickle cell disease, as well as safety and tolerability of melatonin.
Data Sharing Plan
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Data Sharing Plan:
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No
pt-br
No
es
No
Contacts
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Public contact
- Full name: Ilana Rocha Santana
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- Address: R. Cristóvão Colombo, n° 2265 , Jardim Nazareth
- City: São José do Rio Preto / Brazil
- Zip code: 15054-000
- Phone: +55(77)99934-0245
- Email: ilana.santana@unesp.br
- Affiliation: Universidade Estadual Paulista "Júlio De Mesquita Filho"
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Scientific contact
- Full name: Danilo Grunig Da Silva
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- Address: Rua Cristóvão Colombo, n° 2265, Jardim Nazareth
- City: São José do Rio Preto / Brazil
- Zip code: 15054-000
- Phone: +55(18)98143-7130
- Email: danilo.grunig@ufms.br
- Affiliation: Universidade Estadual Paulista "Júlio De Mesquita Filho"
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Site contact
- Full name: Larisssa Paola Venancio
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- Address: Rua da Prainha, n°1326, Morada Nobre
- City: Barreiras / Brazil
- Zip code: 47810-047
- Phone: +55(77)98108-5599
- Email: larissa.venancio@ufob.edu.br
- Affiliation: Universidade Federal do Oeste da Bahia
Additional links:
Total de Ensaios Clínicos 18943.
Existem 9689 ensaios clínicos registrados.
Existem 5215 ensaios clínicos recrutando.
Existem 129 ensaios clínicos em análise.
Existem 6264 ensaios clínicos em rascunho.