HMB + Vitamin D3 for Cerebral Palsy

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Gillette Children's Specialty Healthcare

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a daily supplement of HMB and Vitamin D3 in adolescents with cerebral palsy over a few months. It aims to see if the supplement is safe and acceptable, and whether it improves muscle strength and mobility. HMB and vitamin D3 supplementation has been studied for enhancing muscle strength and physical functionality in older adults, even in individuals not engaged in an exercise training program.

Eligibility Criteria

Adolescents aged 13-17 with cerebral palsy, specifically those who are ambulatory (GMFCS Level I-III) and can follow directions including taking pills daily. They should live near the University of Minnesota, read English, and not be pregnant or planning to become pregnant. Excluded if they've had recent surgeries or certain treatments that affect muscle strength.

Inclusion Criteria

Physical training level expected to remain relatively constant over the study period

I have been diagnosed with cerebral palsy.

Ability to follow directions, including swallowing multiple pills daily and complying with reproductive risk recommendations (post-menarchal females)

+5 more

Exclusion Criteria

I had a selective dorsal rhizotomy surgery within the last year.

I am not scheduled for any treatments that could impact my strength or mobility during the study.

Pregnant, lactating, or trying to become pregnant

+6 more

Participant Groups

The study tests the safety and effects of a daily supplement combo of HMB + Vitamin D3 over 12 weeks on muscle mass, strength, and mobility in adolescents with cerebral palsy. Participants will take these supplements every day and their health changes will be monitored.

1Treatment groups

Experimental Treatment

Group I: HMB + Vitamin D3 SupplementExperimental Treatment1 Intervention

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.