Attention Deficit Hyperactivity Disorder (ADHD)SMART-ADHDNCT07922252
Micronutrient Supplementation and Chronotherapy in Children With ADHD
A study testing Broad-spectrum multivitamin and mineral supplementation and Chronotherapy-Based Lifestyle Guidance in people with Attention Deficit Hyperactivity Disorder (ADHD), run by UCSI University at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Broad-spectrum multivitamin and mineral supplementation and Chronotherapy-Based Lifestyle Guidance
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jan 2027to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
UCSI University
Kuala Lumpur, Kuala Lumpur, 56000
Satvinder Kaur A/P Nachatar Singh, PhD, +60162029941, satvinderkaur@ucsiuniversity.edu.my
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Broad-spectrum multivitamin and mineral supplementation, Chronotherapy-Based Lifestyle Guidance
- Keywords
- ADHD, micronutrient supplementation, omega-3 fatty acids, probiotics, chronotherapy, pediatric nutrition
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad-spectrum multivitamin and mineral supplementationDietary supplement
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.
Chronotherapy-Based Lifestyle GuidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplementation and Chronotherapy Group | Experimental | 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. Receives: Dietary Supplement: Broad-spectrum multivitamin and mineral supplementation; Behavioral: Chronotherapy-Based Lifestyle Guidance |
| Usual Care Control Group | No intervention | Participants will continue their usual care during the 12-week study period without receiving the study nutritional supplements or chronotherapy intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale
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.
Measured: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
Change in ADHD Symptoms Assessed by the SNAP-IV Parent Rating Scale
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.
Measured: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
Secondary outcomes (3)
Change in Sleep Habits and Sleep-Related Difficulties Assessed Using the Children's Sleep Habits Questionnaire (CSHQ)
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.
Measured: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
Change in Objective Sleep-Wake Parameters Measured Using GENEActiv Wrist-Worn Actigraphy
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.
Measured: Baseline (Week 0), Week 6, and Week 12 (7 consecutive days of monitoring at each time point).
Change in Bowel Habits and Gastrointestinal Symptoms Assessed Using a 7-Day Parent-Assisted Bowel Movement Diary
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).
Measured: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up), with a 7-day bowel movement diary at each assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 ratio to either the intervention group receiving nutritional supplementation and chronotherapy guidance or the control group receiving usual care during the 12-week study period.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCSI University
- Sponsor type
- University, hospital or other
- Collaborators
- USANA Health Sciences
- Responsible party
- Principal investigator, Satvinder Kaur, UCSI University
- Investigators
- Satvinder Kaur A/P Nachatar Singh, PhD, Principal investigator, UCSI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922252
- Sponsor's protocol ID
- IEC-2026-FAS-0005
- Other IDs
- RSCH ID-26-04960-LMS
- Acronym
- SMART-ADHD
- Status last verified
- Aug 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Synergistic Effects of Broad-Spectrum Micronutrient Supplementation and Chronotherapy in Malaysian Children With ADHD
- ClinicalTrials.gov ID
- NCT07922252
- Acronym / sponsor ID
- SMART-ADHD / IEC-2026-FAS-0005
- Keywords
- ADHD, micronutrient supplementation, omega-3 fatty acids, probiotics, chronotherapy, pediatric nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- UCSI UniversityUniversity, hospital or other
- Collaborators
- USANA Health Sciences
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 ratio to either the intervention group receiving nutritional supplementation and chronotherapy guidance or the control group receiving usual care during the 12-week study period.
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplementation and Chronotherapy Group | Experimental | Dietary Supplement: Broad-spectrum multivitamin and mineral supplementation, Behavioral: Chronotherapy-Based Lifestyle GuidanceParticipants 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. |
| Usual Care Control Group | No intervention | –Participants will continue their usual care during the 12-week study period without receiving the study nutritional supplements or chronotherapy intervention. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broad-spectrum multivitamin and mineral supplementationParticipants 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. | Dietary supplement | Nutritional Supplementation and Chronotherapy Group |
| Chronotherapy-Based Lifestyle GuidanceParticipants 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. | Behavioural | Nutritional Supplementation and Chronotherapy Group |
Primary outcome
Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale
Time frame: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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.
Change in ADHD Symptoms Assessed by the SNAP-IV Parent Rating Scale
Time frame: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
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.
3 secondary outcomes
Change in Sleep Habits and Sleep-Related Difficulties Assessed Using the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).
Change in Objective Sleep-Wake Parameters Measured Using GENEActiv Wrist-Worn Actigraphy
Time frame: Baseline (Week 0), Week 6, and Week 12 (7 consecutive days of monitoring at each time point).
Change in Bowel Habits and Gastrointestinal Symptoms Assessed Using a 7-Day Parent-Assisted Bowel Movement Diary
Time frame: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up), with a 7-day bowel movement diary at each assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satvinder Kaur A/P Nachatar Singh, PhD principal investigator
UCSI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broad-spectrum multivitamin and mineral supplementation and Chronotherapy-Based Lifestyle Guidance in people with Attention Deficit Hyperactivity Disorder (ADHD), run by UCSI University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Ly Lim, PhD (+60108926366, shuly.olab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale (time frame: Baseline (Week 0), Week 6, Week 12, and Week 24 (3-month follow-up).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.