Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms

Last updated: August 9, 2020
Sponsor: Pekarovics, Susan, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT04510181
SePe-03-2020
  • Ages 18-80
  • All Genders

Study 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 low-normal hGH.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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 SusanPekarovics, MD

  2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50thpercentile for age-appropriate levels)

  3. Female participants of childbearing potential will agree to avoid pregnancy during thestudy.

  4. Capable of giving signed informed consent

Exclusion

Exclusion Criteria:

  1. Human growth hormone deficiency (GHD)

  2. Individuals with a total score of ≥15 (indicating the presence of moderately severemajor depression) or a score of >0 on Item 9 (suicidal ideation) on the Patient HealthQuestionnaire-9 (PHQ-9)

  3. Pregnant women or women who wish to become pregnant

  4. History of substance abuse

  5. Previous treatment with recombinant human growth hormone (rhGH)

  6. Individuals belonging to the following vulnerable populations: people withdisabilities, people who cannot read, educationally disadvantaged, individuals with aserious or life threatening illness, prisoners, non-English speakers, economicallydisadvantaged individuals, employees of the study sponsor/site.

Study Design

Total Participants: 100
Study Start date:
August 01, 2020
Estimated Completion Date:
July 31, 2022

Study 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 studies have demonstrated symptom improvement in individuals with FM and low hGH who received rhGH therapy. The amino acid-based blend represents a novel mechanism for increasing endogenous hGH production. It has been shown to produce an increase in endogenous hGH levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hGH release. The amino acid-based blend may be a safe and effective treatment for FM in individuals with poorly controlled FM and low-normal hGH.

This study will investigate the effect of taking the amino acid blend on IGF-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant FM and low-normal hGH.

After being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. Standard care for fibromyalgia will continue.

Connect with a study center

  • Private Medical Practics of Susan Pekarovics, MD

    Los Angeles, California 90048
    United States

    Active - Recruiting

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