Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
Status unconfirmed · Not applicable
Conditions studied: Fibromyalgia
In brief
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 low-normal hGH.
Key facts
- Study ID
- NCT04510181
- Run by
- Pekarovics, Susan, MD
- People needed
- 100
- Starts
- 2020-08-01
- Expected to finish
- 2022-07-31
- Last updated by the study team
- 2020-08-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Private Medical Practics of Susan Pekarovics, MD — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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