Trial · NCT01039792
Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism
NCT01039792, Phase 2, Phase 3, Completed, University of California, San Francisco; results first posted 2017-02-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism. Trials, record NCT01039792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01039792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Methyl B12 on Behavioral and Metabolic Measures in Children With Autism
- NCT number
- NCT01039792
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Autistic Disorder
- Interventions
- Methyl B12, Placebo
- First posted
- 2009-12-25
- Last updated
- 2017-02-24
- Results first posted
- 2017-02-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression-Improvement (CGI-I) | 8 weeks | PI assesses subject's change using the CGI-I measure. This is a 7-point Likert scale that assesses improvement of the patient's condition. Scores range from the worst score of 7 (Very much worse) to the best score of 1 (Very much improved). Lower scores are better on this scale, and indicate greater improvement. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Global Impression-Improvement (CGI-I) | 8 weeks | comparing placebo vs active B12 subjects | CGI- Improvement | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression-Improvement (CGI-I) | Placebo | 3.1 | Standard Deviation 0.8 | CGI- Improvement | |
| Clinical Global Impression-Improvement (CGI-I) | Active | 2.4 | Standard Deviation 0.8 | CGI- Improvement |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 29 | |
| Overall Study | STARTED | Active | 28 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | Active | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Active | 1 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | cold | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 23 | 2 |
| other | cold | Respiratory, thoracic and mediastinal disorders | Active | 3 | 27 | 3 |
| other | fever | General disorders | Placebo | 1 | 23 | 1 |
| other | fever | General disorders | Active | 2 | 27 | 2 |
| other | increased hyperactivity | Psychiatric disorders | Placebo | 7 | 23 | 7 |
| other | increased hyperactivity | Psychiatric disorders | Active | 2 | 27 | 2 |
| other | mouthing | General disorders | Placebo | 1 | 23 | 1 |
| other | mouthing | General disorders | Active | 5 | 27 | 5 |
| other | trouble sleeping | General disorders | Placebo | 3 | 23 | 3 |
| other | trouble sleeping | General disorders | Active | 1 | 27 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Active | ||
| Total, other adverse events | Placebo | 14 | 23 |
| Total, other adverse events | Active | 13 | 27 |
| Total, serious adverse events | Placebo | 0 | 24 |
| Total, serious adverse events | Active | 0 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26889605 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01039792
GET https://conductscience.org/api/trials/v1/NCT01039792/registered