An interventional study of HMB + Vitamin D3 in Cerebral Palsy, sponsored by Gillette Children's Specialty Healthcare. Active, not recruiting at 1 site in United States. Open to participants aged 13 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Gillette Children's Specialty Healthcare · Not applicable, Interventional, and Other
Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 104 under way, none of them phase 3. Cerebral Palsy · United States.
Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 252nd largest by enrollment of the 296 interventional ones that give a count, is one of 25 that started in 2022, is one of 218 with no phase, reaches primary completion later than 5 of the 103 other live ones, and was the 261st registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →76 of the 372 studies in Cerebral Palsy with a site in United States are open now. Recruiting first, the newest first:
The Foundation for Orthopaedics and Regenerative Medicine · Sites in United States, Greece
University of Washington · Sites in United States
Ages 4–65
University of Wisconsin, Madison · Sites in United States
Ages 7–17
Columbia University · Sites in United States
Ages 18–80
Martin Piazza · Sites in United States
Ages 3–14
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 13 Years to 17 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
372 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 31 · Phase 3 18 · Phase 4 7
First in 1987; this study’s year is marked. 25 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 7 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Median enrollment 25 across the 296 interventional studies, 61 across the 71 observational. Of the 225 that completed or were terminated, 83 (37%) have results posted.
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34 of 372 have an industry lead sponsor. The 10 most frequent:
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Gillette Children's Specialty Healthcare has 7 studies filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
25 of the studies in Cerebral Palsy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT04630392Georgia State UniversityEffects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy | 2026-11-20 |
| NCT05339932Grand Valley State UniversityGrand Valley State University (GVSU) Skills on Wheels | 2026-11-30 |
| NCT06377085Shirley Ryan AbilityLabRepurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy | 2026-12 |
| NCT04897347Teachers College, Columbia UniversityRobotic TruST-Postural Intervention for Children With Cerebral Palsy | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 372 studies in Cerebral Palsy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study of β-hydroxy-β-methylbutyrate (HMB) + Vitamin D3 supplementation in adolescents with cerebral palsy. The primary objective is to quantify safety, compliance, and acceptability of daily combined HMB + Vitamin D3 supplementation for 12 weeks in adolescents with CP. The secondary objective is to quantify changes in lower extremity muscle mass, strength, and functional mobility after daily combined HMB + Vitamin D3 supplementation for 12 weeks.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: HMB + Vitamin D3
Drug pages: Beta-hydroxyisovaleric acid · Cholecalciferol
The supplement will be taken orally twice daily. Participants will take 2 blended HMB + Vitamin D3 tablets in the morning and 2 tablets in the evening for 12 weeks.
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - specific gravity
Specific gravity will be measured via urinalysis with microscopy (unitless; ratio of urine density \[g/cm\^3\] divided by density of pure water).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - pH
pH will be measured via urinalysis with microscopy (usually presented unitless; moles H+ per liter).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - microscopy
Molecular concentrations in urine will be measured via urinalysis with microscopy. The following molecular concentrations will be measured: total protein, glucose, ketones, blood, bilirubin, and urobilinogen (all units: unitless).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - BUN
Blood urea nitrogen (BUN; units: mg/dL) will be measured using a blood sample.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by renal (kidney) function - creatinine
Creatinine will be measured using a blood sample. It will be used to estimate glomerular filtration rate (mL/min/m\^2 body surface area).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by hepatic (liver) function - enzymes
Hepatic enzyme function will be measured with a blood sample. Outcomes include alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\] (all units: units per liter).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events with supplementation as assessed by hepatic (liver) function
Hepatic function will be measured with a blood sample. Outcomes of interest include bilirubin, albumin, and total protein (all units: g/dL).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events before and after supplementation as assessed by adverse events form
Adverse events will be recorded using the NIH's Adverse Events Form, ver 2.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Difference in the incidence of Treatment-Emergent Adverse Events before and after supplementation as assessed by checklist of changes to major organ systems
Common complaints of major organ system experienced over the last 3 days will be self-reported as present or not present for: stomachache, nausea, dizziness, coughing, wheezing, chest pain, weakness, increased headache, negative mood, rash, dry scalp, dry skin, nail changes, ear pain, decreased memory, itching, swelling, diarrhea, stiff joints, nose bleeds, heart burn, numbness, nasal congestion, ringing in ears, increased stress, decreased libido, constipation, shortness of breath, loss of appetite, loss of energy, blood in urine, \& blood in stool.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Ability to comply with HMB supplementation as assessed by a daily diary & compliance check-ins
Participants will complete a daily paper or electronic diary to document taking their supplement. Compliance checks will be conducted by the study staff via a call or email. Unused supplements will be counted at the end of the study. Compliance will be calculated as a percent (# of pills taken on time/total # of pills that should have been taken) x 100.
Time frame: Post-supplementation (12 wks)
Ability to swallow HMB supplement as assessed by the PILL-5 survey
The PILL-5 survey is a 5 question survey that measures physical (e.g., pill sticks in my throat) and emotional (e.g., I have a fear of swallowing pills) swallowing ability. It will be self-reported using a 5-pt Likert scale (never, almost never, sometimes, almost always, always). A total score is calculated (range 0-20, with 20 representing maximum pill dysphasia).
Time frame: Week 1 of supplementation
Palatability of HMB supplement as assessed by the visual 5 faces hedonic scale
Whether participants like or dislike the taste of the supplement will be measured with a 5 faces hedonic scale with the numerical anchors ranging from 1 to 5 (best) and text anchors: dislike a lot; dislike a little; neither like nor dislike; like a little; like a lot.
Time frame: Week 1 of supplementation
Satisfaction of supplement dose volume as assessed by survey
A question will measure if participants felt the dose volume (number of tablets) were acceptable (yes or no).
Time frame: Week 12 of supplementation
Difference in satisfaction of supplement dose frequency as assessed by survey
A question will measure if participants felt the frequency (2 times per day) was acceptable (yes or no).
Time frame: Week 12 of supplementation
Change in lower extremity strength with supplementation as assessed using a Biodex isokinetic system
Isokinetic dynamometry will be used to measure peak torque of hip extensors \& flexors, knee extensors \& flexors, and ankle plantarflexors and dorsiflexors (Newton-meters/body mass).
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Change in muscle mass with supplementation as assessed by dual-energy x-ray absorptiometry (DXA)
Skeletal muscle mass (kg) will be measured using a whole body DXA scan.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Change in functional mobility with supplementation as assessed by the 10-meter walk test (10MWT)
The 10MWT will be performed at the participant's fastest walking speed over a 14-m walkway, with 2-m on each end for acceleration and deceleration. Time to travel the middle 10-m will be recorded by stopwatch and average speed (m/s) calculated. Usual orthoses and assistive devices will be permitted and used at each repeat assessment.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Change in functional mobility with supplementation as assessed by the Timed-up-and-go test (TUG)
The TUG will be performed at self-selected speed using a standard height chair with arms. Participants will stand up, walk 3-m, and return to their seat. Time (seconds) will be measured. Usual orthoses and assistive devices will be permitted and used at each repeat assessment.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Change in functional mobility with supplementation as assessed by the 6 minute walk test (6MWT)
The 6MWT will be performed at the participant's fastest walking speed on an indoor, oval walking path. Distance travelled (m) will be recorded and average speed (m/s) calculated. Usual orthoses and assistive devices will be permitted and used at each repeat assessment.
Time frame: Pre-supplementation (12 wks), post-supplementation (12 wks)
Started May 2022 (actual). Primary completion is estimated for May 2024, 24 months after the start.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 24 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Beta-hydroxyisovaleric acid · Cholecalciferol
Gillette Children's Specialty Healthcare