FibromyalgiaNCT04510181
Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
A study testing amino acid-based blend in people with Fibromyalgia, run by Pekarovics, Susan, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- amino acid-based blend
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Private Medical Practics of Susan Pekarovics, MD
Los Angeles, California, 90048
Kati Kareki, 323-951-4916, kati.kereki@gmail.com
Susan Pekarovics, MD
About this study
Official title: Effect of an Orally Administered Amino Acid-Based Blend on Human Growth Hormone (hGH) Levels and Fibromyalgia (FM) Symptoms: A Prospective, Open-Label, Single-Arm, Observational 24-Week Study in Adults With Poorly Controlled FM and Low hGH
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.
Read the 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 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.
- Conditions
- Fibromyalgia
- Being tested
- amino acid-based blend
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amino acid-based blendDietary supplement
blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia
| Study group | Role | What they receive |
|---|---|---|
| Amino acid-based blend | Experimental | The amino acid-based blend will be administered PO daily for the study duration Receives: Dietary Supplement: amino acid-based blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IGF-1
change from baseline in IGF-1, a surrogate marker of hGH
Measured: 24 weeks, 52 weeks
Secondary outcomes (12)
Fibromyalgia symptoms
Change from baseline in score on the Revised Fibromyalgia Impact Questionnaire (FIQR, a 21-item self-report measure that estimates the severity and impact of FM. Score ranges from 0-100 with higher scores indicating greater severity/impact of FM)
Measured: 24 weeks, 52 weeks
Stress symptoms
Change from baseline in score of the Perceived Stress Scale (PSS, a 10-item self-report measure that assesses the perception of stress. Total score ranges from 0-40 with higher scores indicating greater perceived stress)
Measured: 24 weeks, 52 weeks
Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability
Change from baseline
Measured: 24 weeks, 52 weeks
body weight (kg)
Change from baseline
Measured: 24 weeks, 52 weeks
body mass index (BMI)
Change from baseline
Measured: 24 weeks, 52 weeks
Blood pressure (systolic and diastolic)
Change from baseline
Measured: 24 weeks, 52 weeks
HbA1c
Change from baseline
Measured: 24 weeks, 52 weeks
Fasting total cholesterol
Change from baseline
Measured: 24 weeks, 52 weeks
Fasting HDL cholesterol
Change from baseline
Measured: 24 weeks, 52 weeks
Fasting LDL cholesterol
Change from baseline
Measured: 24 weeks, 52 weeks
Fasting triglycerides
Change from baseline
Measured: 24 weeks, 52 weeks
Fasting glucose
Change from baseline
Measured: 24 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pekarovics, Susan, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Pekarovics, MD, Principal investigator, Pekarovics, Susan, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510181
- Sponsor's protocol ID
- SePe-03-2020
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Orally Administered Amino Acid-Based Blend on Human Growth Hormone (hGH) Levels and Fibromyalgia (FM) Symptoms: A Prospective, Open-Label, Single-Arm, Observational 24-Week Study in Adults With Poorly Controlled FM and Low hGH
- ClinicalTrials.gov ID
- NCT04510181
- Acronym / sponsor ID
- SePe-03-2020
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pekarovics, Susan, MDUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amino acid-based blend | Experimental | Dietary Supplement: amino acid-based blendThe amino acid-based blend will be administered PO daily for the study duration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amino acid-based blendblended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia | Dietary supplement | Amino acid-based blend |
Primary outcome
Change in IGF-1
Time frame: 24 weeks, 52 weeks
change from baseline in IGF-1, a surrogate marker of hGH
12 secondary outcomes
Fibromyalgia symptoms
Time frame: 24 weeks, 52 weeks
Stress symptoms
Time frame: 24 weeks, 52 weeks
Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability
Time frame: 24 weeks, 52 weeks
body weight (kg)
Time frame: 24 weeks, 52 weeks
body mass index (BMI)
Time frame: 24 weeks, 52 weeks
Blood pressure (systolic and diastolic)
Time frame: 24 weeks, 52 weeks
HbA1c
Time frame: 24 weeks, 52 weeks
Fasting total cholesterol
Time frame: 24 weeks, 52 weeks
Fasting HDL cholesterol
Time frame: 24 weeks, 52 weeks
Fasting LDL cholesterol
Time frame: 24 weeks, 52 weeks
Fasting triglycerides
Time frame: 24 weeks, 52 weeks
Fasting glucose
Time frame: 24 weeks, 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: Yes. Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Pekarovics, MD principal investigator
Pekarovics, Susan, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amino acid-based blend in people with Fibromyalgia, run by Pekarovics, Susan, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kati Kareki (323-951-4916, kati.kereki@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IGF-1 (time frame: 24 weeks, 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.