HMB Cerebral Palsy Pilot Study

Gillette Children's

Status: Active, not recruiting

Conditions: Cerebral Palsy

Treatments: Dietary Supplement: HMB + Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05384951

STUDY00015262

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

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 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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

HMB + Vitamin D3 Supplement

Experimental group

Description:

Supplement delivery will be a tablet containing both HMB \& Vitamin D3. HMB will be administered in its calcium salt form. One tablet will contain 750 mg HMB + 250 IU of Vitamin D3. The target dosage is 3 g HMB + 1000 IU of Vitamin D3 per day.

Treatment:

Dietary Supplement: HMB + Vitamin D3