What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy that focus on muscle protein synthesis and bone health, such as botulinum toxin (BoNT) injections and vitamin D supplementation, have specific side effects. BoNT injections can lead to transient, mild complications such as localized pain, weakness, and in rare cases, more severe reactions like difficulty swallowing or breathing. Long-term use of BoNT may not prevent contractures or reduce the need for orthopedic surgery. Vitamin D supplementation is generally well-tolerated, but high doses can cause hypercalcemia, leading to nausea, vomiting, weakness, and serious complications like kidney damage. Combining HMB with Vitamin D3 aims to improve muscle mass and bone health, but the safety and efficacy of this combination specifically in CP patients are still under investigation.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for cerebral palsy that focus on muscle protein synthesis and bone health similar to HMB + Vitamin D3. However, treatments for cerebral palsy often include medications like baclofen, which has shown some efficacy in improving functional mobility in children with spastic quadriplegic cerebral palsy. Additionally, general management of cerebral palsy may involve multimodal treatments including physical therapy, nutritional support, and other pharmacological interventions to address muscle tone and overall health.

What other types of research exist?

Promising, novel alternatives to HMB + Vitamin D3 for muscle protein synthesis and bone health in Cerebral Palsy patients include amino acids (e.g., taurine, lysine), antioxidants (e.g., coenzyme Q10), and mindfulness therapy. Additionally, acupuncture and chiropractic care may be considered, though their efficacy and safety should be discussed with a healthcare provider.

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Dietary Supplement

HMB + Vitamin D3 for Cerebral Palsy

N/A

Waitlist Available

Research Sponsored by Gillette Children's Specialty Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with cerebral palsy

13-17 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-supplementation (12 wks), post-supplementation (12 wks)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a pilot study primarily focused on safety, compliance, and acceptability of HMB + Vitamin D3 supplementation for adolescents with CP, detailed side effects are not listed but may include typical reactions to dietary supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with cerebral palsy.

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I am between 13 and 17 years old.

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I can walk with or without assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have a kidney condition.

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I am not allergic or sensitive to any medications or supplements.

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I have a liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-supplementation (12 wks), post-supplementation (12 wks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-supplementation (12 wks), post-supplementation (12 wks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-supplementation (12 wks), post-supplementation (12 wks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability to comply with HMB supplementation as assessed by a daily diary & compliance check-ins

Ability to swallow HMB supplement as assessed by the PILL-5 survey

Difference in satisfaction of supplement dose frequency as assessed by survey

+11 more

Secondary study objectives

Change in functional mobility with supplementation as assessed by the 10-meter walk test (10MWT)

Change in functional mobility with supplementation as assessed by the 6 minute walk test (6MWT)

Change in functional mobility with supplementation as assessed by the Timed-up-and-go test (TUG)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) that focus on muscle protein synthesis and bone health include nutritional supplements like β-hydroxy-β-methylbutyrate (HMB) and Vitamin D3. HMB is a metabolite of the amino acid leucine and plays a crucial role in muscle protein synthesis by promoting muscle growth and reducing muscle breakdown. Vitamin D3 is essential for calcium absorption and bone health, which is particularly important for CP patients who often have compromised mobility and are at risk for bone density loss. These treatments matter for CP patients as they can help improve muscle mass, strength, and functional mobility, thereby enhancing overall quality of life and reducing the risk of fractures and other complications associated with poor bone health.