HMB + Vitamin D3 Supplement for Cerebral Palsy
Phase-Based Progress Estimates
Effectiveness
Safety
Gillette Children's Specialty Healthcare, Saint Paul, MN
Cerebral Palsy
HMB + Vitamin D3 - DietarySupplementEligibility
< 18
All Sexes
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Eligibility
< 18
All Sexes
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Study 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 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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
14 Primary · 5 Secondary · Reporting Duration: Pre-supplementation (12 wks), post-supplementation (12 wks)
Post-supplementation (12 wks)
Ability to comply with HMB supplementation as assessed by a daily diary & compliance check-ins
Pre-supplementation (12 wks), post-supplementation (12 wks)
Change in functional mobility with supplementation as assessed by the 10-meter walk test (10MWT)
Change in functional mobility with supplementation as assessed by the 6 minute walk test (6MWT)
Change in functional mobility with supplementation as assessed by the Timed-up-and-go test (TUG)
Change in lower extremity strength with supplementation as assessed using a Biodex isokinetic system
Change in muscle mass with supplementation as assessed by dual-energy x-ray absorptiometry (DXA)
Difference in the incidence of Treatment-Emergent Adverse Events before and after supplementation as assessed by adverse events form
Difference in the incidence of Treatment-Emergent Adverse Events before and after supplementation as assessed by checklist of changes to major organ systems
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by hepatic (liver) function
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by hepatic (liver) function - enzymes
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - BUN
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - creatinine
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - microscopy
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - pH
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - specific gravity
Week 1 of supplementation
Ability to swallow HMB supplement as assessed by the PILL-5 survey
Palatability of HMB supplement as assessed by the visual 5 faces hedonic scale
Week 12 of supplementation
Difference in satisfaction of supplement dose frequency as assessed by survey
Satisfaction of supplement dose volume as assessed by survey
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
HMB + Vitamin D3 Supplement
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: HMB + Vitamin D3 Supplement · No Placebo Group · N/A
HMB + Vitamin D3 Supplement
DietarySupplement
Experimental Group · 1 Intervention: HMB + Vitamin D3 · Intervention Types: DietarySupplementTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-supplementation (12 wks), post-supplementation (12 wks)
Trial Background
Elizabeth Boyer, Clinical Scientist
Principal Investigator
Gillette Children's Specialty Healthcare
Closest Location: Gillette Children's Specialty Healthcare · Saint Paul, MN
2013First Recorded Clinical Trial
13 TrialsResearching Cerebral Palsy
31 CompletedClinical Trials
Eligibility Criteria
Age < 18 · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are 13 to 17 years old.
You must be able to read and write English.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments