Clinical trial NCT05234593: Feasibility and Acceptability of Powdered Multinutrient Formula
Official title: Feasibility and Acceptability Study of a Powdered Multinutrient Formula in Children With Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility
Primary purpose: OTHER

Brief summary: The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.

Detailed description: The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. A limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the Tasso device-collected plasma. Parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. This study will inform us whether a larger efficacy study is possible in this population.

Eligibility criteria: Inclusion Criteria:

1. Age inclusive of and between 7 and 16 years at the time of enrollment
2. Verbally willing to ingest one EmpowerPlus Lightning Stick daily
3. Attend all virtual study appointments and complete questionnaires
4. Have been previously enrolled in a multinutrient study OR complete a screening to match with participants from that study in terms of age and symptoms of ADHD and emotional dysregulation
5. Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
6. Willing to collect blood and urine samples, once, at home.

Exclusion Criteria\*:

1. Neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition
2. Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
3. Known allergy to any ingredients of the intervention
4. Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
5. Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
6. Any disability that would interfere with participant answering questions verbally
7. Non-English speaking
8. Pregnancy or sexually active at baseline. \*Exclusion criteria will be based on parent/guardian report on child. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participants may be reviewed virtually by study physician in the case of any concerns about participation.

Primary outcomes:
measure: Feasibility measured by count of remaining Sticks
timeFrame: week 6
measure: Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
timeFrame: week 6
Secondary outcomes:
measure: Feasibility measured by count of participants who provide blood using the Tasso device
timeFrame: once, at baseline
measure: Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
timeFrame: once, at baseline
measure: Feasibility measured by count of participants who provide the dried urine sample
timeFrame: once, at baseline
measure: Acceptability measured by a 'yes' response to their preference of using the at-home dried urine sample collection method instead of a lab-based urine sample collection method
timeFrame: once, at baseline
measure: Feasibility of remote study visits measured by count of participants who complete all online remote study visits
timeFrame: week 6
measure: Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
timeFrame: week 6
measure: Monitor participants for side effects by count of 'yes' if listed symptoms are new or have increased in severity, using the question format from the Pediatric Adverse Events Rating Scale
timeFrame: week 6
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeanette Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References: