Micronutrient Supplementation in Children With ASD

NCT05268744 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 22-35971
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label examination of changes in metabolites with use of micronutrients in children with autism spectrum disorder (ASD). Investigators will also measure behavioral measures monthly at school with teachers and parents report.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Change in the Autism Behavior Inventory, Short Form (ABI-S)

  The ABI-S is an observer-reported outcome scale designed specifically to measure change and severity of Autism Spectrum Disorder (ASD) symptoms. ABI-S will be measured by both parents and teachers. There are 24 questions. The scoring of ABI-S questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total range of score is between 0 and 72. Lower score indicates better performance.

  Baseline to Week 8

• Change in the Social Responsiveness Scale (SRS)

  SRS measures social ability in children and young adults. SRS will be measured by both parents and teachers. There are 65 questions. The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Lower score indicates better performance.

  Baseline to Week 8

Study Arms (1)

Micronutrient

EXPERIMENTAL

In this open-label trial, all subjects will receive the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It will be delivered in a powder form taken sublingually.

Drug: Micronutrient

Interventions

Micronutrient DRUG

Subject will take micronutrient supplement daily for 8 weeks

Micronutrient

Eligibility Criteria

• Age: 5 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female, enrolled at Oak Hill School (OHS), age 6-22 and with a diagnosis of ASD.
• ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
• Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

You may not qualify if:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
• Taking multivitamins currently and unwilling to stop during the study period

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Micronutrients

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

The limited sample size (N=11) has indeed constrained the statistical power of the analysis. The absence of a control group prevents direct comparisons between treated participants and untreated individuals, limiting our ability to isolate the effects of the micronutrient supplement from other confounding factors. We do not have information regarding the types of diets the participants were on which could have influenced their response to the micronutrient supplementation.

Results Point of Contact

• Title: Dr. Robert Hendren
• Organization: UCSF

robert.hendren@ucsf.edu

(415) 476-7500

Study Officials

• Robert Hendren, DO

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: November 14, 2022
• Primary Completion: January 14, 2023
• Study Completion: January 30, 2023
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)