A Folinic Acid Intervention for Autism Spectrum Disorders
This study is currently recruiting participants.
Verified January 2013 by University of Arkansas
Sponsor:
University of Arkansas
Collaborators:
Arkansas Children's Hospital Research Institute
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01602016
First received: May 15, 2012
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
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 blood tests. Children in the placebo group during phase 2 will be offered to receive 12 weeks of the folinic acid intervention after they have completed Phase 2.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Spectrum Disorder Autistic Disorder Autism Asperger's Syndrome Pervasive Development Disorders |
Drug: Folinic Acid and placebo Drug: Folinic Acid |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Folinic Acid Intervention for ASD: Links to Folate Receptor-alpha Autoimmunity & Redox Metabolism |
Resource links provided by NLM:
Genetics Home Reference related topics:
Asperger syndrome
MedlinePlus related topics:
Asperger Syndrome
Autism
B Vitamins
Speech and Language Problems in Children
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- Language Improvement [ Time Frame: (baseline and 12 weeks ) ] [ Designated as safety issue: No ]Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.
Secondary Outcome Measures:
- Improved Stereotyped Behavior and Improved Social Skills [ Time Frame: (baseline, 6, and 12 weeks) ] [ Designated as safety issue: No ]Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, BASC, AIM, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, BASC, AIM and SRS) will be the secondary outcomes.
| Estimated Enrollment: | 130 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Phase I
Baseline Visit Phase 1: The screening portion of the CELF will be administered to the child to screen for language impairment. If there is no language impairment, the subject will not be eligible. If language impairment is confirmed, the participant will immediately go on to the baseline visit of Phase 2.
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Phase II: 12 week Folinic Acid or Placebo intervention
The child will be consented for Phase 2 (the RCT) and undergo a blood draw (up to 20mL) for metabolic and autoantibody testing. the child will undergo language and behavioral assessment while the parent will be interviewed for the Vineland and other questionnaires (AIM, ASQ, BASC, SRS, and ABC). Demographic information including; age, race, gender, and ethnicity will be collected. The research pharmacist will randomize the participant to either Intervention A or B (only the research pharmacist will know which intervention has the folinic acid). The research pharmacist will distribute the drug or placebo to the parent and instruct the parent of the proper administration of the intervention. This will be considered the 12 week randomly controlled clinical trial that is investigating the safety and efficacy of folinic acis interventions in ASD and will last for approximately 12 weeks. At the end of 12 weeks, the same assessments that were conducted at baseline will be readministered
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Drug: Folinic Acid and placebo
Capsules of folinic acid and placebo will be administered in 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated for 10 weeks.
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Experimental: Phase III: Open Label Extension of Folinic Acid
If consent for Phase 3 is signed by parents with children who qualify for Phase 3, the research pharmacist will provide a 12 week supply of folinic acid to the parent. This arm will be offered to all clients that were on placebo for the 12 week intervention study. After consenting and 12 weeks of folinic acid dosing, the client will come back and complete the same protocol and be tested on the same measures used in phase II of the study.
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Drug: Folinic Acid
capsules of folinic acis will be provided. The target dose will be 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated, for 10 weeks.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Autism Spectrum Disorder (As defined by a gold standard measure for ASD diagnosis: the Autism Diagnostic Observation Schedule, Autism Diagnostic Interview, and/or the minimum Arkansas state requirement for autism classification, as defined by a consensus diagnosis of ASD by a medical doctor, speech pathologist, and psychologist.).
- 3 years to 14 years of age.
- Language Impairment (as defined by the CELF).
- Ability to maintain other complementary, traditional, and/or behavioral interventions constant during the study.
- Unchanged complementary, traditional, and/or behavioral intervention 8 weeks prior to study entry.
- No profound sensory deficits that could obscure the integrity of the data
Exclusion Criteria:
- Antipsychotic medication
- Mineral or Vitamin Supplementation that exceeds the FDA or IOM Recommended Daily Allowance.
- Severe irritability (as defined by an Aberrant Behavior Checklist irritability subscale >17 ).
- Prematurity (<34 weeks gestation) as determined by medical history.
- Current gastroesophageal reflux or current or past history of liver or kidney disease.
- Drugs known to affect folate metabolism (e.g., methotrexate) and their derivatives.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602016
Contacts
| Contact: John C Slattery, BA/CCRP | 501-364-3556 | jcslattery@uams.edu |
| Contact: Hannah Feild, BA | 501-364-4665 | FeildHannahC@uams.edu |
Locations
| United States, Arkansas | |
| Arkansas Children's Hospital Research Institute | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: John C Slattery, BA/CCRP 501-364-3556 jcslattery@uams.edu | |
| Principal Investigator: Richard E Frye, M.D./Ph.D. | |
| Sub-Investigator: S. Jill James, Ph.D. | |
Sponsors and Collaborators
University of Arkansas
Arkansas Children's Hospital Research Institute
State University of New York - Downstate Medical Center
Investigators
| Principal Investigator: | Richard E Frye, M.D./Ph.D. | Director of Autism Research |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT01602016 History of Changes |
| Other Study ID Numbers: | 136002 |
| Study First Received: | May 15, 2012 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
ASD PDD-NOS |
Additional relevant MeSH terms:
|
Autistic Disorder Asperger Syndrome Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Leucovorin Folic Acid Levoleucovorin Vitamin B Complex Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013