TerminatedPhase 2

A Folinic Acid Intervention for Autism Spectrum Disorders

Stopped: Non-compliance

United States99 participantsStarted 2012-05

Plain-language summary

Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.

Who can participate

Age range

3 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * 1\. Autism Spectrum Disorder (as defined by a gold standard measure for ASD diagnosis: the Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised). In an event where sufficient diagnostic information is lacking, and the PI believes that the clients meet all other inclusion criteria and a prospective diagnosis of an ASD is clinically warranted, and a formal diagnosis is scheduled to occur within a reasonable time frame from the date of study entry but before dispersing study drug/placebo, then the client may be considered as potentially eligible. Furthermore, a research-reliable rater must complete the diagnosis. * 2\. 3 years to 14 years of age * 3\. Language Impairment * 4\. Ability to maintain complementary, traditional, and/or behavioral interventions and to attempt to keep them constant during the study, when possible. * 5\. Unchanged complementary, traditional, and/or behavioral intervention for approximately 8 weeks prior to study entry, when possible. Exclusion Criteria * 1\. Currently taking Antipsychotic medication * 2\. Vitamin or Element Supplementation that exceeds the IOM Tolerable Upper Intake Levels * 3\. Any moderate to severe positive response on that Aberrant Behavior Checklist Irritability subscale on questions: Injures self on purpose, is aggressive to other children or adults (verbally or physically), deliberately hurts himself/herself, and/or does physical violence to self. * 4\. Prematurity (\<34 weeks …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Language Improvement

Timeframe: (baseline and 12 weeks )

Trial details

NCT IDNCT01602016

SponsorUniversity of Arkansas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2016-11-04

View on ClinicalTrials.gov More Autism Spectrum Disorder trials