Micronutrient Supplementation and Chronotherapy in Children With ADHD (SMART-ADHD)
A Randomized Controlled Trial Evaluating the Synergistic Effects of Broad-Spectrum Micronutrient Supplementation and Chronotherapy in Malaysian Children With ADHD
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children that can affect attention, behavior, learning, and daily functioning. Nutritional status, gut health, and sleep and circadian patterns may influence ADHD-related symptoms.
This randomized controlled trial will evaluate the effects of a 12-week intervention combining broad-spectrum multivitamin-mineral supplementation (Usanimals™) with chronotherapy-based lifestyle guidance in Malaysian children aged 6-12 years with ADHD. The intervention includes Usanimals™ supplementation and guidance on sleep routines and meal timing. Participants will be randomly allocated to either the intervention group or a control group receiving usual care.
Changes in ADHD-related symptoms will be assessed using validated parent-reported measures, including the SNAP-IV and Conners questionnaires. Sleep patterns and gastrointestinal outcomes will also be evaluated. The study aims to determine whether this combined micronutrient and lifestyle approach may improve ADHD-related symptoms, sleep, and gastrointestinal outcomes compared with usual care.
Descripción general del estudio
Estado
Descripción detallada
ADHD is a multifactorial neurodevelopmental condition involving alterations in several biological processes related to attention and behavioral regulation. Nutritional factors, including micronutrients and omega-3 fatty acids, may contribute to neurotransmitter synthesis and function, while the gut microbiota may influence neurobiological processes through the gut-brain axis. Sleep disturbances and altered sleep-wake patterns are also commonly reported among children with ADHD.
The SMART-ADHD study evaluates an integrative intervention combining broad-spectrum multivitamin-mineral supplementation (Usanimals™) with chronotherapy-related lifestyle guidance. Children aged 6-12 years who meet the study eligibility criteria will be randomly allocated to an intervention or control group. The intervention group will receive Usanimals™ multivitamin-mineral supplementation, consisting of two chewable tablets daily (one after breakfast and one after dinner), together with guidance related to sleep routines and meal timing for 12 weeks. The proposed paediatric supplementation dosage is subject to regulatory confirmation prior to implementation. The control group will continue usual care during the 12-week active trial period and will subsequently be offered Usanimals™ supplementation for three months as delayed supplementation.
ADHD-related symptoms will be evaluated using the SNAP-IV and Conners parent questionnaires. Sleep-related outcomes will be assessed using the Children's Sleep Habits Questionnaire (CSHQ) and objective sleep-wake monitoring using the GENEActiv wrist-worn actigraphy device. Gastrointestinal outcomes will include bowel movement frequency and stool characteristics assessed using the Modified Bristol Stool Form Scale for Children (mBSFS-C). Assessments will be conducted at Week 0, Week 6, Week 12, and Week 24 according to the study protocol, with GENEActiv monitoring conducted at Weeks 0, 6, and 12.
The study will evaluate whether combining Usanimals™ multivitamin-mineral supplementation with chronotherapy-based lifestyle guidance is associated with improvements in ADHD-related symptoms and selected sleep and gastrointestinal outcomes compared with usual care. The Week 24 follow-up will provide additional information on the maintenance of outcomes and exploratory findings following delayed supplementation in the control group.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shu Ly Lim, PhD
- Número de teléfono: +60108926366
- Correo electrónico: shuly.olab@gmail.com
Ubicaciones de estudio
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 56000
- Reclutamiento
- UCSI University
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Contacto:
- Satvinder Kaur A/P Nachatar Singh, PhD
- Número de teléfono: +60162029941
- Correo electrónico: satvinderkaur@ucsiuniversity.edu.my
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- Children who meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) or children with elevated parent-reported ADHD symptoms who meet at least one of the prespecified CPRS-48 or parent SNAP-IV screening thresholds at Week 0, as described in Screening and Eligibility. Children with parent-reported ASD Level 1 may also be included, provided they meet all ADHD screening and other eligibility criteria.
- Aged 6-12 years.
- Able to comply with the study procedures, medication schedule, and follow-up visits.
- Written informed consent has been obtained from the parent or legal guardian.
Exclusion criteria:
- Children with Autism Spectrum Disorder (ASD) Level 2 or Level 3, or with an ASD diagnosis of unknown severity that cannot be confirmed as Level 1 based on existing information.
- A diagnosed intellectual disability or an intelligence quotient (IQ) below 70.
- Presence of cardiac disease or liver disease.
- Participation in another clinical trial within the specified washout period.
- Presence of a diagnosed bleeding disorder or significant history of abnormal bleeding.
- Presence of any known or suspected immunocompromising condition.
- Any medical condition (e.g., severe allergies to fish/seafood or acute systemic diseases) or behavioral condition (e.g., acute psychiatric crises) that would compromise the participant's safety or the integrity of the study data.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Nutritional Supplementation and Chronotherapy Group
Participants will receive the study nutritional supplementation consisting of a broad-spectrum multivitamin and mineral supplement together with chronotherapy-based guidance on sleep and meal timing. |
Participants will receive USANA Usanimals Chewable Tablets for 12 weeks at a dose of 2 tablets daily: 1 tablet after breakfast and 1 tablet after dinner. Participants in the intervention group will receive chronotherapy-based lifestyle guidance for 12 weeks, focusing on maintaining consistent sleep and wake times, regular meal timing, and alignment of daily routines with circadian rhythms. Parents or caregivers will be provided with guidance to support implementation and adherence throughout the intervention period. |
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Sin intervención: Usual Care Control Group
Participants will continue their usual care during the 12-week study period without receiving the study nutritional supplements or chronotherapy intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale
Periodo de tiempo: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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ADHD symptoms will be assessed using the Conners Parent Rating Scale. The primary outcome will evaluate the change in parent-reported ADHD symptom severity from baseline to Week 12, with particular emphasis on the Inattention domain. Higher scores indicate greater ADHD symptom severity; therefore, a reduction in score from baseline indicates improvement in symptoms. |
Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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Change in ADHD Symptoms Assessed by the SNAP-IV Parent Rating Scale
Periodo de tiempo: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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ADHD symptoms will be assessed using the Swanson, Nolan, and Pelham Rating Scale-IV (SNAP-IV). Changes in parent-reported Inattention and Hyperactivity/Impulsivity symptom scores from baseline to Week 12 will be evaluated. Higher scores indicate greater ADHD symptom severity; therefore, a reduction in score indicates improvement. |
Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Sleep Habits and Sleep-Related Difficulties Assessed Using the Children's Sleep Habits Questionnaire (CSHQ)
Periodo de tiempo: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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Changes in children's sleep habits and sleep-related difficulties will be assessed using the parent-reported Children's Sleep Habits Questionnaire (CSHQ). The questionnaire evaluates sleep-related domains including bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Changes in total CSHQ scores and relevant subscale scores from baseline will be assessed during the intervention period and at the 3-month follow-up. Higher scores indicate greater sleep-related difficulties. |
Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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Change in Objective Sleep-Wake Parameters Measured Using GENEActiv Wrist-Worn Actigraphy
Periodo de tiempo: Baseline (Week 0), Week 6, and Week 12 (7 consecutive days of monitoring at each time point).
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Objective sleep-wake patterns will be assessed using the GENEActiv wrist-worn actigraphy device in both intervention and control groups. Participants will wear the device for 7 consecutive days at each assessment time point. Actigraphy-derived outcomes will include sleep duration, sleep efficiency, sleep onset time, wake time, and sleep timing. Changes from baseline will be evaluated at Week 6 and Week 12 to assess the effects of the combined multivitamin-mineral supplementation and chronotherapy intervention on objective sleep-wake patterns. |
Baseline (Week 0), Week 6, and Week 12 (7 consecutive days of monitoring at each time point).
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Change in Bowel Habits and Gastrointestinal Symptoms Assessed Using a 7-Day Parent-Assisted Bowel Movement Diary
Periodo de tiempo: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up), with a 7-day bowel movement diary at each assessment.
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Changes in bowel habits will be assessed using a 7-day parent-assisted bowel movement diary. Parents or caregivers will record daily bowel movement frequency, stool form using the Modified Bristol Stool Form Scale for Children (mBSFS-C), and associated gastrointestinal symptoms, including straining and abdominal pain. Outcomes will include average bowel movement frequency, distribution of stool form categories, and frequency of reported gastrointestinal symptoms. Changes from baseline will be evaluated at Week 6, Week 12, and the 3-month follow-up (Week 24). |
Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up), with a 7-day bowel movement diary at each assessment.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Satvinder Kaur A/P Nachatar Singh, PhD, UCSI University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IEC-2026-FAS-0005
- RSCH ID-26-04960-LMS (Identificador de registro: National Medical Research Register (NMRR), Malaysia)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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