HMB Cerebral Palsy Pilot Study
Status unconfirmed · Not applicable
Conditions studied: Cerebral Palsy
In brief
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 daily combined HMB + Vitamin D3 supplementation for 12 weeks in adolescents with CP. The secondary objective is to quantify changes in lower extremity muscle mass, strength, and functional mobility after daily combined HMB + Vitamin D3 supplementation for 12 weeks.
Key facts
- Study ID
- NCT05384951
- Run by
- Gillette Children's Specialty Healthcare
- People needed
- 7
- Starts
- 2022-05-15
- Expected to finish
- 2024-05-31
- Last updated by the study team
- 2024-02-22
Who can join
Age: 13 and older, up to 17. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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