Could a Vitamin-Like supplement boost language in kids with autism?
NCT ID NCT04060017
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether leucovorin calcium, a vitamin-like supplement, can improve language and other symptoms in young children with autism spectrum disorder. Researchers will enroll 80 children aged 2.5 to 5 years with language delays. The trial lasts about 26 weeks and compares the supplement to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- leucovorin calcium (a vitamin-like supplement)
- What this could lead to
- If it works, this could point toward a safe supplement to help improve language and other symptoms in young children with autism.
- What could go wrong
- This is a small, early-phase trial with only 80 children. Results may not apply to all kids with autism, and the supplement may not work better than placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2020
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 60 months
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Autism Spectrum Disorder (as defined below). 2. Between 2 years 6 months and 5 years 2 months of age at baseline 3. Language impairment (Ages and Stage Questionnaire between -1 and -3 SD for Language) 4. Has at least 4 month old expressive language ability as assessed by the MSEL Expressive Language Scale (i.e., Parent answers "yes" to " Voluntary babbling (such as 'bu, bu, bu")" Question #7 on the MSEL Expressive Language Scale. 5. English included in the languages in which the child is being raised 6. Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment, so fulfilling #1 and #4 fulfills this requirement. 6\. Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period 7. Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry Exclusion Criteria: 1. Known FRAA status by clinically validated test performed outside of research studies. 2. Mineral or vitamin supplementation that exceeds the Tolerable Upper Daily Intake Levels set by the Institute of Medicine (See Table 5 below) 3. Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior 4. Severely affected as defined by CGI-Severity Standard Score = 7 (Extremely Ill) 5. Severe prematurity (\<34 weeks gestation) as determined by medical history 6. Current uncontrolled gastroesophageal reflux 7. Current or history of liver or kidney disease as determined by medical history and safety labs 8. Genetic syndromes 9. Congenital brain malformations 10. Epilepsy 11. Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data 12. Significant negative reaction (i.e. fainting, vomiting, etc.) because of a previous blood draw. 13. Failure to thrive or Body Mass Index \< 5%ile or \<5%ile for weight (male \<11.2kg; female \<10.8kg by CDC 2000 growth charts) at the time of screening. 14. Concurrent treatment with drug that would significantly interact with l-leucovorin such as specific chemotherapy agents, antimalarial and immune suppressive agents and select antibiotics (See Table 6 below). 15. Allergy or Sensitivity to ingredients in the investigational product or placebo 16. Evaluation with the MSEL or BOSCC within 3 months of entering the study 17. Planned evaluation with the MSEL or BOSCC during the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autism spectrum disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Southwestern Autism Research & Resource Center
Phoenix, Arizona, 85016, United States
-
State University of New York, Downstate
Brooklyn, New York, 11203, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can wireless monitors make ER vitals easier for autistic children?
- Why do some children with autism struggle with balance?
- Brain zaps tested to calm emotional storms in autism
- Can an AI chatbot help autism caregivers find their way?
- Pregnancy and birth clues: what raises autism risk?
- Can virtual reality boost thinking skills in kids with autism?