Status:
ACTIVE_NOT_RECRUITING
HMB Cerebral Palsy Pilot Study
Lead Sponsor:
Gillette Children's Specialty Healthcare
Collaborating Sponsors:
University of Minnesota
Metabolic Technologies, LLC
Conditions:
Cerebral Palsy
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy. The primary objective is to quantify safety, compliance, and acceptability of...
Eligibility Criteria
Inclusion
- Diagnosed with cerebral palsy
- Spastic or mixed tone
- GMFCS Level I-III (i.e., ambulatory)
- 13-17 years old
- Physical training level expected to remain relatively constant over the study period
- Ability to follow directions, including swallowing multiple pills daily and complying with reproductive risk recommendations (post-menarchal females)
- Within reasonable driving distance to the University of Minnesota - Twin Cities
- Reads English
Exclusion
- Pregnant, lactating, or trying to become pregnant
- Surgery in the past 9 months
- Botulinum toxin injections in past 3 months
- Selective dorsal rhizotomy in the past 12 months
- Upcoming invasive treatment within the study period that may affect strength or functional mobility (e.g., surgery, botulinum toxin injections, intrathecal baclofen pump or dosage change)
- Liver disease or liver disorder
- Kidney disease or disorder
- Prescription drug or nutrition supplement contraindications
- Excessive research or medical-related radiation exposure in the past 12 months (approximately 500 mrem or greater)
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05384951
Start Date
May 15 2022
End Date
May 31 2024
Last Update
February 22 2024
Active Locations (1)
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1
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101