HMB Cerebral Palsy Pilot Study

Browse trials for

• Cerebral Palsy 1,848

Keywords

• HMB
• Vitamin D
• Safety
• Compliance
• Strength
• Muscle Mass
• Mobility
• β-hydroxy-β-methylbutyrate
• Calcium β-hydroxy-β-methylbutyrate

Study arms

• Experimental
  HMB + Vitamin D3 Supplement

  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

Interventions

• Dietary supplementHMB + Vitamin D3

  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.

Primary outcomes

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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)

8. 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)

9. 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)

10. 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)

11. 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

12. 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

13. 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

14. 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

Secondary outcomes

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)