Creatine Supplementation in Autism Spectrum Disorder

NCT ID: NCT04498078

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2025-05-02

Brief Summary

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Autism Spectrum Disorder (ASD) is accompanied by reduced levels of total creatine in right temporal-parietal junction and other brain regions of interest, and addressing this deficit by exogenous administration of creatine may have beneficial effects on brain metabolism and disease-specific clinical symptoms in patients suffering from ASD.

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Creatine

Twenty grams per day b.i.d.

Group Type EXPERIMENTAL

Creatine

Intervention Type DIETARY_SUPPLEMENT

Creatine monohydrate (20 g per day)

Interventions

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Creatine

Creatine monohydrate (20 g per day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 10 years and above
* Informed consent signed by a parent or legal guardian or legal representative
* Diagnostic and Statistical Manual of Mental Disorders-IV criteria for ASD.

Exclusion Criteria

* Pregnant or nursing female patients
* Non-pharmacologic therapy
* Current diagnosis of other mental disorder
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergej Ostojic, MD, PhD

Role: STUDY_CHAIR

Applied Bioenergetics Lab

Locations

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FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, Serbia

Site Status

Countries

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Serbia

References

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Edmondson DA, Xia P, McNally Keehn R, Dydak U, Keehn B. A Magnetic Resonance Spectroscopy Study of Superior Visual Search Abilities in Children with Autism Spectrum Disorder. Autism Res. 2020 Apr;13(4):550-562. doi: 10.1002/aur.2258. Epub 2020 Jan 7.

Reference Type BACKGROUND
PMID: 31909886 (View on PubMed)

Other Identifiers

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ABL-21-AUCR

Identifier Type: -

Identifier Source: org_study_id