Effect of an Amino-Acid-Based Blend on Human Growth Hormo... | NCT04510181

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

NCT04510181

Sponsor

Pekarovics, Susan, MD

Status

Unknown status

Last Update Posted

Aug 12, 2020Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

amino acid-based blend

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Jul 31, 2022Estimated

First Submitted Date

Aug 6, 2020

First Submission Date that Met QC Criteria

Aug 9, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Amino acid-based blend	Experimental	The amino acid-based blend will be administered PO daily for the study duration	Dietary Supplement: amino acid-based blend

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amino acid-based blend	Dietary Supplement	blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia	Amino acid-based blend

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in IGF-1	change from baseline in IGF-1, a surrogate marker of hGH	24 weeks, 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)	24 weeks, 52 weeks
Stress symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kati Kareki	Contact	323-951-4916		kati.kereki@gmail.com

Overall Officials

Name	Affiliation	Role
Susan Pekarovics, MD	Pekarovics, Susan, MD	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Private Medical Practics of Susan Pekarovics, MD	Recruiting	Los Angeles	California	90048	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol

Time Frame

Beginning 6 months after publication

Access Criteria

Upon appropriate data request by other scientists

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided