Back to resultsFeasibility and Acceptability of Powdered Multinutrient Formula
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EmpowerPlus Lightning Sticks
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit Hyperactivity Disorder
Eligibility Criteria
Inclusion Criteria:
- Age inclusive of and between 7 and 16 years at the time of enrollment
- Verbally willing to ingest one EmpowerPlus Lightning Stick daily
- Attend all virtual study appointments and complete questionnaires
- 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
- Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
- Willing to collect blood and urine samples, once, at home.
Exclusion Criteria*:
- 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
- Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
- Known allergy to any ingredients of the intervention
- Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
- Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
- Any disability that would interfere with participant answering questions verbally
- Non-English speaking
- 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.
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lightning Stick
Arm Description
Feasibility and acceptability
Outcomes
Primary Outcome Measures
Feasibility measured by count of remaining Sticks
Feasibility will be determined if consumption of one Lightning Stick daily is achieved when greater than or equal to 80% of provided Sticks were taken.
Measured by count of remaining (unused) Sticks.
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
Acceptability of taking the Lightning Sticks will be measure through 7 questions with a 6-point Likert-scale, (range: Strongly Disagree to Strongly Agree) Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking powdered multinutrients is acceptable, at or above the Agree range.
Secondary Outcome Measures
Feasibility measured by count of participants who provide blood using the Tasso device
At-home collection of blood with the Tasso device will be considered feasible if greater than or equal to 70% of children provide the sample.
Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the Tasso at-home collection method instead of going to a lab to provide the blood sample.
Feasibility measured by count of participants who provide the dried urine sample
At-home collection of dried urine samples will be considered feasible if greater than or equal to 70% of children provide the sample.
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
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the at-home dried urine collection method instead of going to a lab to provide the urine sample.
Feasibility of remote study visits measured by count of participants who complete all online remote study visits
Feasibility will be determined if greater than or equal to 70% of parents/guardians complete all three remote visits
Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
Acceptability will be measured if greater than or equal to 70% of parents state they preferred completing online remote study visits instead of in-person study visits
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
Parent and child report of side effects, including: headache, dry mouth, sleep disruptions, nausea, irritability, fatigue, anxiety, changes in appetite, skin rash, migraines, and other (specify what symptom).
Full Information
NCT ID
NCT05234593
First Posted
January 19, 2022
Last Updated
June 25, 2023
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT05234593
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lightning Stick
Arm Type
Other
Arm Description
Feasibility and acceptability
Intervention Type
Dietary Supplement
Intervention Name(s)
EmpowerPlus Lightning Sticks
Intervention Description
multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue
Primary Outcome Measure Information:
Title
Feasibility measured by count of remaining Sticks
Description
Feasibility will be determined if consumption of one Lightning Stick daily is achieved when greater than or equal to 80% of provided Sticks were taken.
Measured by count of remaining (unused) Sticks.
Time Frame
week 6
Title
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
Description
Acceptability of taking the Lightning Sticks will be measure through 7 questions with a 6-point Likert-scale, (range: Strongly Disagree to Strongly Agree) Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking powdered multinutrients is acceptable, at or above the Agree range.
Time Frame
week 6
Secondary Outcome Measure Information:
Title
Feasibility measured by count of participants who provide blood using the Tasso device
Description
At-home collection of blood with the Tasso device will be considered feasible if greater than or equal to 70% of children provide the sample.
Time Frame
once, at baseline
Title
Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
Description
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the Tasso at-home collection method instead of going to a lab to provide the blood sample.
Time Frame
once, at baseline
Title
Feasibility measured by count of participants who provide the dried urine sample
Description
At-home collection of dried urine samples will be considered feasible if greater than or equal to 70% of children provide the sample.
Time Frame
once, at baseline
Title
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
Description
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the at-home dried urine collection method instead of going to a lab to provide the urine sample.
Time Frame
once, at baseline
Title
Feasibility of remote study visits measured by count of participants who complete all online remote study visits
Description
Feasibility will be determined if greater than or equal to 70% of parents/guardians complete all three remote visits
Time Frame
week 6
Title
Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
Description
Acceptability will be measured if greater than or equal to 70% of parents state they preferred completing online remote study visits instead of in-person study visits
Time Frame
week 6
Title
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
Description
Parent and child report of side effects, including: headache, dry mouth, sleep disruptions, nausea, irritability, fatigue, anxiety, changes in appetite, skin rash, migraines, and other (specify what symptom).
Time Frame
week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age inclusive of and between 7 and 16 years at the time of enrollment
Verbally willing to ingest one EmpowerPlus Lightning Stick daily
Attend all virtual study appointments and complete questionnaires
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
Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
Willing to collect blood and urine samples, once, at home.
Exclusion Criteria*:
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
Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
Known allergy to any ingredients of the intervention
Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
Any disability that would interfere with participant answering questions verbally
Non-English speaking
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette Johnstone, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Feasibility and Acceptability of Powdered Multinutrient Formula
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