Autism Spectrum DisorderPhase 2NCT05013164
Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
A Phase 2 study testing Folinic Acid in people with Autism Spectrum Disorder, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Folinic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 30 Mar 2021
- Phase
- Phase 2
- 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 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by DSM-5 Criteria, Childhood Autism Rating Scale (CARS) scoring and clinical examination along with documentation of Language Impairment
Who cannot join
- All children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children's Hospital and Institute of Child Health
Multan, Punjab Province, 60650
About this study
No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Folinic Acid
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folinic AcidDrug
Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Folinic Acid + Behavioral Therapy | Experimental | Children receiving folinic acid and behavioral therapy. Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks. Receives: Drug: Folinic Acid |
| Behavioral Therapy | No intervention | Children received only behavioral therapy for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders
Outcome measures were based on Autism Symptoms Questionnaire (Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, et al. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Molecular Psychiatry. 2016;23(2):1-10. doi:10.1038/mp.2016.168). Primary outcome measures was language improvement and adaptive skills (gross motor development age, self-help).
Measured: 12 weeks
Secondary outcomes (1)
To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders
Secondary outcome measures were improvement in stereotype movements, verbal communication, hyperactivity, peer relationship and inattention based on Autism Symptoms Questionnaire (Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, et al. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Molecular Psychiatry. 2016;23(2):1-10. doi:10.1038/mp.2016.168)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Oct 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hashim Raza, Nishtar Medical University
- Investigators
- Fawwad Saleem, FCPS, Principal investigator, ICH Multan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013164
- Sponsor's protocol ID
- ICHMultan
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Folinic Acid in Improving the Adaptive Skills and Language Impairment in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05013164
- Acronym / sponsor ID
- ICHMultan
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 19 Aug 2021 (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.
No such study has been conducted in Pakistan so the primary objective of this study was to determine the role of folinic acid in improving the speech and adaptive skills while secondary objective was improvement of stereotype movements and hyperactivity in ASD among children aged 3 to 14 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Folinic Acid + Behavioral Therapy | Experimental | Drug: Folinic AcidChildren receiving folinic acid and behavioral therapy. Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks. |
| Behavioral Therapy | No intervention | –Children received only behavioral therapy for 12 weeks. |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of both genders aged 3 to 14 years with diagnosis of autism spectrum disorder established by DSM-5 Criteria, Childhood Autism Rating Scale (CARS) scoring and clinical examination along with documentation of Language Impairment
Key exclusion criteria (1 listed)
- All children having autism with seizure disorder, autism with serious medical illness within last 6 months or those with autism with well-defined genetic syndrome.
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 |
|---|---|---|
| Folinic AcidFolinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks | Drug | Folinic Acid + Behavioral Therapy |
Primary outcome
To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders
Time frame: 12 weeks
Outcome measures were based on Autism Symptoms Questionnaire (Frye RE, Slattery J, Delhey L, Furgerson B, Strickland T, Tippett M, et al. Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial. Molecular Psychiatry. 2016;23(2):1-10. doi:10.1038/mp.2016.168). Primary outcome measures was language improvement and adaptive skills (gross motor development age, self-help).
1 secondary outcome
To dertermine improvement of stereotype movements and hyperactivity in children with autism spectrum disorders
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
Fawwad Saleem, FCPS principal investigator
ICH Multan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Folinic Acid in people with Autism Spectrum Disorder, run by Nishtar Medical University at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the role of folinic acid in improving the speech and adaptive skills among children with autism spectrum disorders (time frame: 12 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 24 Aug 2021.