Status:
UNKNOWN
Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
Lead Sponsor:
Pekarovics, Susan, MD
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by IGF-1) and clinical symptoms in individuals with treatment-resistant FM and lo...
Detailed Description
Low hGH levels have been observed in approximately 1/3 of individuals with FM. Low hGH levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with FM and several st...
Eligibility Criteria
Inclusion
- Have a clinical diagnosis of FM for at least 10 years, poorly controlled FM symptom, and receiving standard of care treatment at the Private Medical Practice of Susan Pekarovics, MD
- Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)
- Female participants of childbearing potential will agree to avoid pregnancy during the study.
- Capable of giving signed informed consent
Exclusion
- Human growth hormone deficiency (GHD)
- Individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of \>0 on Item 9 (suicidal ideation) on the Patient Health Questionnaire-9 (PHQ-9)
- Pregnant women or women who wish to become pregnant
- History of substance abuse
- Previous treatment with recombinant human growth hormone (rhGH)
- Individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor/site.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04510181
Start Date
August 1 2020
End Date
July 31 2022
Last Update
August 12 2020
Active Locations (1)
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1
Private Medical Practics of Susan Pekarovics, MD
Los Angeles, California, United States, 90048