HMB + Vitamin D3 for Cerebral Palsy

Overseen By Marissa Thill, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Gillette Children's Specialty Healthcare

Disqualifiers: Pregnancy, Recent surgery, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

7 Participants Needed

What You Need to Know Before You Apply

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.

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.

How does the HMB + Vitamin D3 treatment for cerebral palsy differ from other treatments?

The HMB + Vitamin D3 treatment is unique because it combines HMB, which may help with muscle health, with Vitamin D3, which is crucial for bone health and is often deficient in children with cerebral palsy. This combination targets both muscle and bone issues, which are common in cerebral palsy, unlike other treatments that may focus on just one aspect. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment HMB + Vitamin D3 for cerebral palsy?

Research shows that children with cerebral palsy often have low levels of vitamin D, which can lead to weaker bones. Supplementing with vitamin D3 has been shown to increase vitamin D levels in these children, potentially improving bone health. ^{1 2 4 6 7}

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)

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

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?

Group I: HMB + Vitamin D3 Supplement Experimental Treatment 1 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.

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

1. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes of children and adolescents who had cerebral palsy with secondary osteoporosis. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Musculoskeletal Health in Active Ambulatory Men with Cerebral Palsy and the Impact of Vitamin D. [2021]

3. Iran pubmed.ncbi.nlm.nih.gov

Prevalence of Vitamin D Deficiency and Associated Risk Factors in Cerebral Palsy A study in North-West of Iran. [2022]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Vitamin D deficiency in children with cerebral palsy: A narrative review of epidemiology, contributing factors, clinical consequences and interventions. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

High-dose vitamin D supplementation in children with cerebral palsy or neuromuscular disorder. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Effect of impaired ambulation and anti-epileptic drug intake on vitamin D status of children with cerebral palsy. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Use of Vitamin D Bolus in Fortified Juice for Improving Vitamin D Status in Children with Cerebral Palsy. [2022]