Trials / Unknown
UnknownNCT05384951
HMB Cerebral Palsy Pilot Study
β-hydroxy-β-methylbutyrate (HMB) Pilot Feasibility and Efficacy Study in Cerebral Palsy (CP)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Gillette Children's Specialty Healthcare · Academic / Other
- Sex
- All
- Age
- 13 Years – 17 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-05-15
- Primary completion
- 2024-05-31
- Completion
- 2024-05-31
- First posted
- 2022-05-23
- Last updated
- 2024-02-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05384951. Inclusion in this directory is not an endorsement.