Recruiting

Amino-Acid Blend

Sponsor:

Pekarovics, Susan, MD

Code:

NCT04510181

Conditions

Fibromyalgia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

amino acid-based blend

Study Details

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 low-normal hGH.

Conditions

Fibromyalgia

Study ID

NCT04510181

Start date

Aug 1, 2020

Status verified date

Aug, 2020

Completion date

Jul 31, 2022

Anticipated

Primary completion date

Jul 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Susan Pekarovics, MD
2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)
3. Female participants of childbearing potential will agree to avoid pregnancy during the study.
4. Capable of giving signed informed consent

Exclusion Criteria:

1. Human growth hormone deficiency (GHD)
2. 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)
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 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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amino acid-based blend

The amino acid-based blend will be administered PO daily for the study duration

Interventions

amino acid-based blend

blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia

Primary outcome measure

  • Change in IGF-1 [ Time Frame: 24 weeks, 52 weeks ]

Central Contacts and Locations

Central contacts

Locations

Private Medical Practics of Susan Pekarovics, MD

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Susan Pekarovics, MD

More Information

Sponsor

Pekarovics, Susan, MD

Last update posted

Aug 12, 2020

Last verified

Aug, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pekarovics, Susan, MD on 2020-08-12.