Short-Term Safety of Low-Dose Creatine Hydrochloride: A 2... | NCT07521059

Studies
Short-Term Safety of Low-Dose Creatine Hydrochloride: A 28-Day Single-Arm Pilot Study

NCT07521059

Sponsor

Vireo Systems, Inc.

Status

Completed

Last Update Posted

Apr 9, 2026Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Safety of Short Term Creatine Hydrochloride Dosing

Interventions

creatine supplementation

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

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2024Actual

Primary Completion Date

Jul 3, 2024Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Apr 2, 2026

First Submission Date that Met QC Criteria

Apr 2, 2026

First Posted Date

Apr 9, 2026Actual

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

Apr 2, 2026

Last Update Posted Date

Apr 9, 2026Actual

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

Background: Creatine monohydrate (typically 5-20 g/day) has a well-established safety profile across diverse populations. Creatine hydrochloride (CR-HCl) is a highly soluble creatine formulation that may allow effective supplementation at substantially lower doses (750 mg - 3 g/day); however, controlled human safety data specific to CR-HCl remain limited.

Objective: To evaluate the short-term laboratory safety and tolerability of low-dose CR-HCl supplementation administered for 28 days in healthy adults.

Detailed Description

Not provided

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A 750mg/day	Experimental		Dietary Supplement: creatine supplementation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
creatine supplementation	Dietary Supplement	750 mg/day dosing	Group A 750mg/day

Measure	Description	Time Frame
No adverse events		over 28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy adults

Exclusion Criteria:

consumed creatine supplements in last 30 days significant medical conditions that could affect outcomes (e.g., diabetes)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princeton Consumer Research		Raritan	New Jersey	08869	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003401	Creatine

Ancestor Terms

ID	Term
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D000596	Amino Acids

Browse Leaves

Not provided

Browse Branches

Not provided