Trial Outcomes & Findings for ScanBrit Dietary Intervention in Autism (NCT NCT00614198)

Last Updated: 2010-10-01

Results Overview

ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): \<80 low probability of autism, 81-90 below average, 91-110 average, \>110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): \<69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), \>130 (high). ADHD-IV: 0=no problems indicated. \>11 attention \& \>11 hyperactivity = ADHD diagnosis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Baseline - 8 months - 12 months - 24 months

Results posted on

2010-10-01

Participant Flow

Recruitment via multiple associations

92 participants were initially identified for possible study recruitment. 82 participants were available for possible study allocation; 10 participants dropped out prior to randomisation for various reasons, leaving 72 participants.

Participant milestones

Participant milestones
Measure	Gluten- and Casein-free Dietary Intervention Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).	No Gluten- and Casein-free Dietary Intervention Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
Stage 1 STARTED	38	34
Stage 1 COMPLETED	26	29
Stage 1 NOT COMPLETED	12	5
Stage 2 STARTED	26	29
Stage 2 COMPLETED	18	17
Stage 2 NOT COMPLETED	8	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ScanBrit Dietary Intervention in Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gluten- and Casein-free Dietary Intervention n=38 Participants Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).	No Gluten- and Casein-free Dietary Intervention n=34 Participants Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).	Total n=72 Participants Total of all reporting groups
Age, Categorical <=18 years	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	8.22 years STANDARD_DEVIATION 1.99 • n=5 Participants	8.13 years STANDARD_DEVIATION 2.03 • n=7 Participants	8.15 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Region of Enrollment Denmark	38 participants n=5 Participants	34 participants n=7 Participants	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - 8 months - 12 months - 24 months

Population: Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention).

Outcome measures

Outcome measures
Measure	Gluten- and Casein-free Dietary Intervention n=26 Participants Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).	No Gluten- and Casein-free Dietary Intervention n=29 Participants Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Communication (8 months)	-0.16715 Units on a scale Standard Error 0.10127	0.08235 Units on a scale Standard Error 0.12096
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Communication (24 months)	-0.16176 Units on a scale Standard Error 0.1204	0.18529 Units on a scale Standard Error 0.11926
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Social (8 months)	0.016807 Units on a scale Standard Error 0.1024	0.02521 Units on a scale Standard Error 0.12203
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Social (24 months)	-0.5042 Units on a scale Standard Error 0.09795	0.02521 Units on a scale Standard Error 0.13709
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Repetitive behaviours (8 months)	-0.14706 Units on a scale Standard Error 0.0894	0.03431 Units on a scale Standard Error 0.1139
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADOS - Reptitive behaviours (24 months)	-0.14216 Units on a scale Standard Error 0.0782	-0.0049 Units on a scale Standard Error 0.10042
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Social (8 months)	-1.07692 Units on a scale Standard Error 0.29382	-0.06897 Units on a scale Standard Error 0.27152
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Social (12 months)	-1.57692 Units on a scale Standard Error 0.3097	-0.42308 Units on a scale Standard Error 0.36867
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Social (24 months)	-1.88235 Units on a scale Standard Error 0.57447	-1.11765 Units on a scale Standard Error 0.50645
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Communication (8 months)	-1.23077 Units on a scale Standard Error 0.38554	-0.51724 Units on a scale Standard Error 0.40203
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Communication (12 months)	-1.47826 Units on a scale Standard Error 0.37125	-1.46154 Units on a scale Standard Error 0.40089
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Communication (24 months)	-2 Units on a scale Standard Error 0.42875	-1.29412 Units on a scale Standard Error 0.60491
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Stereotyped behaviours (8 months)	-0.96154 Units on a scale Standard Error 0.32572	-0.7931 Units on a scale Standard Error 0.41338
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Stereotyped behaviours (12 months)	-1.46154 Units on a scale Standard Error 0.33389	-1.3333 Units on a scale Standard Error 0.39943
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. GARS - Stereotyped behaviours (24 months)	-0.88235 Units on a scale Standard Error 0.44459	-1.70588 Units on a scale Standard Error 0.52696
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Communication (8 months)	0.23077 Units on a scale Standard Error 1.35227	1.25 Units on a scale Standard Error 1.73176
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Communication (12 months)	0.92308 Units on a scale Standard Error 2.71629	1.85714 Units on a scale Standard Error 2.05204
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Communication (24 months)	1.27778 Units on a scale Standard Error 3.61895	-2.05882 Units on a scale Standard Error 3.19175
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Social (8 months)	1.53846 Units on a scale Standard Error 2.03676	0.92857 Units on a scale Standard Error 2.63369
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Social (12 months)	-4.15385 Units on a scale Standard Error 2.39467	-3.25 Units on a scale Standard Error 2.59406
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Social (24 months)	0.72222 Units on a scale Standard Error 3.17033	-3.29412 Units on a scale Standard Error 4.29412
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Daily Living (8 months)	3.03846 Units on a scale Standard Error 2.54043	-1.64286 Units on a scale Standard Error 2.90785
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Daily Living (12 months)	3.46154 Units on a scale Standard Error 2.79903	-2.85714 Units on a scale Standard Error 2.8857
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. VABS - Daily Living (24 months)	-0.16667 Units on a scale Standard Error 2.94974	-4.64706 Units on a scale Standard Error 4.46715
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV - Inattention (8 months)	-2.15385 Units on a scale Standard Error 0.916	0.31034 Units on a scale Standard Error 0.65296
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV - Inattention (12 months)	-2.19231 Units on a scale Standard Error 0.88582	-0.03704 Units on a scale Standard Error 0.69488
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV - Inattention (24 months)	-2.29412 Units on a scale Standard Error 0.89016	-3.35294 Units on a scale Standard Error 1.14706
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV - Hyperactivity (8 months)	-2.03846 Units on a scale Standard Error 0.80667	-0.17241 Units on a scale Standard Error 0.60186
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV - Hyperactivity (12 months)	-1.69231 Units on a scale Standard Error 0.86606	-0.92593 Units on a scale Standard Error 0.55451
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. ADHD-IV Hyperactivity (24 months)	-2.58824 Units on a scale Standard Error 1.12805	-4.17647 Units on a scale Standard Error 1.22845

SECONDARY outcome

Timeframe: Baseline - 8 months -12 months - 24 months

Outcome measures

Outcome data not reported

Adverse Events

Gluten- and Casein-free Dietary Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Gluten- and Casein-free Dietary Intervention

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

Lennart Pedersen

Center for Autisme

Phone: 44982355

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place