Status:
COMPLETED
Feasibility and Acceptability of Powdered Multinutrient Formula
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
7-16 years
Phase:
NA
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 onl...
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 onl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05234593
Start Date
August 1 2022
End Date
April 30 2023
Last Update
April 4 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239