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Dietary Supplement
Creatine Supplementation for Age-Related Voice Change
N/A
Waitlist Available
Led By Aaron Johnson
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 10
Awards & highlights
Study Summary
This trial will test if taking creatine can help seniors improve hearing, perception, physical, and reporting outcomes. 20 people will get creatine or placebo.
Who is the study for?
This trial is for people over 65 who want to improve their voice performance and are willing to undergo voice therapy. It's not suitable for those with heart failure, kidney or liver disease, certain blood test abnormalities, a history of vocal fold procedures, larynx lesions unrelated to aging, cognitive disabilities, or those on specific medications like NSAIDs.Check my eligibility
What is being tested?
The study aims to see if creatine supplements can help older adults with age-related changes in their voices. Participants will be randomly given either creatine monohydrate or a placebo and monitored for any improvements in voice quality and function.See study design
What are the potential side effects?
While the side effects aren't detailed here, creatine is generally considered safe but can sometimes cause muscle cramping, nausea, diarrhea and may affect kidney function especially in those with pre-existing conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Decibel (dB) Output during Aerodynamic Analysis of Voice
Average Expert Rating of Change in Glottal Closure
Average Expert Rating of Change in Mucosal Wave
+3 moreSide effects data
From 2015 Phase 4 trial • 14 Patients • NCT0151463071%
Cold and flu symptoms
29%
Diarrhea
21%
Stomach Discomfort
14%
Muscle Cramps
7%
Lightheaded
7%
Numbness and Tingling in hands
7%
Headache
7%
Indigestion
7%
Polydipsia
7%
Swelling in Hands
7%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Creatine Monohydrate
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Creatine SupplementationExperimental Treatment1 Intervention
Participants randomized to receive creatine. Study participants will be asked to track their daily administration on a log provided by the study team.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to receive placebo. Study participants will be asked to track their daily administration on a log provided by the study team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Creatine monohydrate
2005
Completed Phase 4
~620
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,701 Total Patients Enrolled
Aaron JohnsonPrincipal InvestigatorAaron.Johnson@nyulangone.org
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with congestive heart failure.I have a kidney condition.I have unusual changes in my voice box not due to getting older.I have a liver condition.I am not willing to undergo voice therapy.I want to take part in voice therapy.I have had procedures to enhance my vocal cords.I am 65 years old or older.I am currently taking medication that can affect my kidney function.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Creatine Supplementation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I become involved in this clinical research?
"Those hoping to join this medical research must have vocal changes that are a result of their age and also be between the ages of 65 and 100. As it stands, approximately 20 people need to participate in the trial."
Answered by AI
Do the requirements for this medical experiment extend to those of advanced age?
"This clinical trial's age requirements are between 65 and 100."
Answered by AI
Are there any current vacancies for participants in this clinical investigation?
"According to the clinicaltrials.gov records, this medical trial is not currently accepting patients as it was last updated on May 4th 2023. Nevertheless, there are additional trials that one can participate in at this juncture."
Answered by AI
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