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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shu Ly Lim, PhD
- 전화번호: +60108926366
- 이메일: shuly.olab@gmail.com
연구 장소
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, 말레이시아, 56000
- 모병
- UCSI University
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연락하다:
- Satvinder Kaur A/P Nachatar Singh, PhD
- 전화번호: +60162029941
- 이메일: satvinderkaur@ucsiuniversity.edu.my
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Sleep Habits and Sleep-Related Difficulties Assessed Using the Children's Sleep Habits Questionnaire (CSHQ)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Satvinder Kaur A/P Nachatar Singh, PhD, UCSI University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IEC-2026-FAS-0005
- RSCH ID-26-04960-LMS (레지스트리 식별자: National Medical Research Register (NMRR), Malaysia)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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