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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing if a combination of two supplements, β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3, is safe and effective in improving muscle mass, strength, and mobility in adolescents with cerebral palsy.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gillette Children's Specialty HealthcareLead Sponsor

30 Previous Clinical Trials

11,495 Total Patients Enrolled

13 Trials studying Cerebral Palsy

5,874 Patients Enrolled for Cerebral Palsy

University of MinnesotaOTHER

1,379 Previous Clinical Trials

1,588,489 Total Patients Enrolled

5 Trials studying Cerebral Palsy

4,603 Patients Enrolled for Cerebral Palsy

Metabolic Technologies, LLCUNKNOWN

Media Library

HMB (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05384951 — N/A

Cerebral Palsy Research Study Groups: HMB + Vitamin D3 Supplement

Cerebral Palsy Clinical Trial 2023: HMB Highlights & Side Effects. Trial Name: NCT05384951 — N/A

HMB (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384951 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially participate in this trial?

"This trial is taking on 10 young patients (ages 13 to 17) with cerebral palsy. In addition to the age requirement, they must also be ambulatory and classified as having spastic or mixed tone; able to follow instructions including swallowing multiple pills daily and complying with reproductive risk protocols; located within reasonable driving distance of the University of Minnesota - Twin Cities; and capable of reading English."

Answered by AI

What results is the research team attempting to obtain?

"Within a 24-week time frame, this trial aims to establish the impact of supplementation on Treatment-Emergent Adverse Events as measured by renal (kidney) function - specific gravity. Secondary endpoints include assessments made using dual energy x-ray absorptiometry (DXA) scans in order to calculate skeletal muscle mass; 10 meter walk test and Timed Up and Go Test conducted at self selected speeds with usual orthoses or assistive devices used for each repeat assessment."

Answered by AI

Is this experiment accepting participants currently?

"According to the data hosted on clinicaltrials.gov, this study is no longer inviting prospective patients as of June 6th 2022. Initially posted 15 May 2022, it has since been discontinued; however there are still 154 other medical trials actively recruiting right now."

Answered by AI