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HMB Cerebral Palsy Pilot Study

NCT05384951 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-02-22

No results posted yet for this 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.

Conditions

  • Cerebral Palsy

Interventions

DIETARY_SUPPLEMENT

HMB + Vitamin D3

The supplement will be taken orally twice daily. Participants will take 2 blended HMB + Vitamin D3 tablets in the morning and 2 tablets in the evening for 12 weeks.

Sponsors & Collaborators

  • University of Minnesota

    collaborator OTHER

  • Metabolic Technologies, LLC

    collaborator UNKNOWN

  • Gillette Children's Specialty Healthcare

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384951 on ClinicalTrials.gov