HMB Cerebral Palsy Pilot Study

Last updated: February 21, 2024
Sponsor: Gillette Children's Specialty Healthcare
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

HMB + Vitamin D3

Clinical Study ID

NCT05384951
STUDY00015262
  • Ages 13-17
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 complyingwith reproductive risk recommendations (post-menarchal females)
  • Within reasonable driving distance to the University of Minnesota - Twin Cities
  • Reads English

Exclusion

Exclusion Criteria:

  • 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 orfunctional mobility (e.g., surgery, botulinum toxin injections, intrathecal baclofenpump 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)

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: HMB + Vitamin D3
Phase:
Study Start date:
May 15, 2022
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

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