HMB + Vitamin D3 for Cerebral Palsy

EB
MT
Overseen ByMarissa Thill, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Gillette Children's Specialty Healthcare
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety, ease of use, and effects of a daily supplement combination of HMB (a compound that may aid muscle growth) and Vitamin D3 for adolescents with cerebral palsy. The researchers aim to determine if these supplements can improve muscle mass, strength, and movement over a 12-week period. Teens aged 13-17 with cerebral palsy who can walk and live near the University of Minnesota might be suitable candidates for this study. Participants should also be able to follow instructions, such as taking pills daily. As an unphased trial, this study offers a unique opportunity for participants to contribute to groundbreaking research that could enhance the quality of life for adolescents with cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have prescription drug or nutrition supplement contraindications (reasons not to take them together), you may not be eligible to participate.

Is there any evidence suggesting that the HMB + Vitamin D3 supplementation is safe for adolescents with cerebral palsy?

Research has shown that taking HMB in doses of 1.5 to 3 grams per day is safe for humans for at least one year. The study uses a dose of 3 grams per day, which falls within this safe range. Most reports mention only mild side effects, such as stomach discomfort, and some studies have found no negative effects at all.

Vitamin D3 is usually well-tolerated, especially at the study's dose of 1000 IU per day. This amount is commonly found in supplements and is considered safe for most people.

Overall, existing research suggests that the combination of HMB and Vitamin D3 is expected to be safe. However, monitoring for any side effects and discussing any concerns with the research team or a healthcare provider is important.12345

Why are researchers excited about this trial?

Researchers are excited about using HMB and Vitamin D3 for cerebral palsy because this combination focuses on muscle health and bone strength, which are crucial for individuals with this condition. Unlike traditional treatments that might center on managing symptoms through physical therapy or medications, HMB (a compound that helps reduce muscle breakdown) and Vitamin D3 (essential for bone health) offer a novel approach by potentially enhancing physical capabilities directly. The convenience of a tablet format also makes it easy to administer, ensuring consistent dosing.

What evidence suggests that HMB + Vitamin D3 might be an effective treatment for cerebral palsy?

Research has shown that HMB, a compound that helps build muscle, and Vitamin D3 may improve muscle mass and strength. Studies have found that HMB increases muscle size and strength in both young and older adults. Vitamin D3 supports muscle function and maintains bone health. Although specific data for people with cerebral palsy is limited, this trial will evaluate the combined effects of HMB and Vitamin D3 supplements on muscle improvement in this population, drawing on their effects in other groups.12678

Are You a Good Fit for This Trial?

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)
See 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
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily combined HMB + Vitamin D3 supplementation

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HMB
  • Vitamin D3
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: HMB + Vitamin D3 SupplementExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gillette Children's Specialty Healthcare

Lead Sponsor

Trials
31
Recruited
8,100+

University of Minnesota

Collaborator

Trials
1,459
Recruited
1,623,000+

Metabolic Technologies, LLC

Collaborator

Trials
1
Recruited
7+

Citations

HMB Cerebral Palsy Pilot Study - Découvrir facilement des...This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy.
HMB Cerebral Palsy Pilot Study | Clinical Research Trial ...This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy.
HMB + Vitamin D3 for Cerebral Palsy · Info for ParticipantsThis 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 ...
A double-blind placebo controlled trial into the impacts of ...For example, chronic HMB supplementation has been shown to increase muscle mass and strength in younger individuals undergoing RET [13] and also in older women ...
International society of sports nutrition position stand: β- ...The results indicated that both 2 and 4 weeks of HMB supplementation improved the recovery of MVC torque and range of motion compared to a placebo while ...
Hydroxymethylbutyrate (Hmb) - Uses, Side Effects, and MoreSupplementation with a combination of beta-hydroxy-beta-methylbutyrate (HMB), arginine, and glutamine is safe and could improve hematological parameters. JPEN J ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/10917905/
beta-hydroxy-beta-methylbutyrate (HMB) supplementation ...Although several reports in animals and humans indicate that HMB is safe, quantitative safety data in humans have not been reported definitively.
HMB benefits, dosage, and side effectsAlthough most studies report mild side effects (e.g., gastrointestinal discomfort) with HMB, other studies have reported no adverse effects. A study in college- ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security