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Trial Outcomes & Findings for Micronutrient Supplementation in Children With ASD (NCT NCT05268744)

NCT ID: NCT05268744

Last Updated: 2024-02-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2024-02-29

Participant Flow

Participant milestones

Participant milestones
Measure
All Participants
All participants received the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It was delivered in a powder form and taken sublingually.
Overall Study
STARTED
16
Overall Study
COMPLETED
11
Overall Study
NOT COMPLETED
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=11 Participants
All participants received the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It was delivered in a powder form and taken sublingually.
Age, Categorical
<=18 years
11 Participants
n=11 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=11 Participants
Age, Categorical
>=65 years
0 Participants
n=11 Participants
Sex: Female, Male
Female
2 Participants
n=11 Participants
Sex: Female, Male
Male
9 Participants
n=11 Participants
Region of Enrollment
United States
11 Participants
n=11 Participants
Autism Behavior Inventory - Short (ABI-S)
ABI-S (Parent)
25.3 units on a scale
STANDARD_DEVIATION 3.5 • n=11 Participants
Autism Behavior Inventory - Short (ABI-S)
ABI-S (Teacher)
21.6 units on a scale
STANDARD_DEVIATION 10.7 • n=11 Participants
Social Responsiveness Scale (SRS)
SRS (Parent)
94.4 units on a scale
STANDARD_DEVIATION 23.8 • n=11 Participants
Social Responsiveness Scale (SRS)
SRS (Teacher)
69 units on a scale
STANDARD_DEVIATION 24.1 • n=11 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

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.

Outcome measures

Outcome measures
Measure
All Participants
n=11 Participants
All participants received the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It was delivered in a powder form and taken sublingually.
Change in the Autism Behavior Inventory, Short Form (ABI-S)
ABI-S (Parent)
-2.9 score on a scale
Interval -7.1 to 1.4
Change in the Autism Behavior Inventory, Short Form (ABI-S)
ABI-S (Teacher)
-0.8 score on a scale
Interval -4.4 to 2.8

PRIMARY outcome

Timeframe: Baseline to Week 8

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.

Outcome measures

Outcome measures
Measure
All Participants
n=11 Participants
All participants received the daily dose of micronutrient, in the form of one lightning stick per day, which contains 2.9 grams of micronutrients per stick. It was delivered in a powder form and taken sublingually.
Change in the Social Responsiveness Scale (SRS)
SRS (Parent)
-8.1 score on a scale
Interval -18.4 to 2.2
Change in the Social Responsiveness Scale (SRS)
SRS (Teacher)
0.8 score on a scale
Interval -9.8 to 11.4

Adverse Events

All Study Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Hendren

UCSF

Phone: (415) 476-7500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place