Trial · NCT00348933
Dietary Supplements for the Treatment of Angelman Syndrome
NCT00348933, Not applicable, Completed, University of California, San Diego; results first posted 2012-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dietary Supplements for the Treatment of Angelman Syndrome. Trials, record NCT00348933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00348933
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dietary Supplements for the Treatment of Angelman Syndrome
- NCT number
- NCT00348933
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 90 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Angelman Syndrome, Nervous System Diseases
- Interventions
- Betaine, Creatine, Metafolin, Vitamin B12
- First posted
- 2006-07-06
- Last updated
- 2012-09-24
- Results first posted
- 2012-09-24
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Baseline, 1 year | Primary: Bayley Scales of Infant Development measures Mental Developmental Index standard scores 0 (least skilled) - 100 (most skilled) Psychomotor Developmental Index standard scores 0 (least skilled - 10 (most skilled) Vineland Adaptive Behavior Scales (VABS), Communication standard scores 0 (least skilled) - 100 (most skilled) Daily Living Skills standard scores 0 (least skilled) - 100 (most skilled) Socialization standard scores 0 (least skilled) - 100 (most skilled) Motor Skills standard scores 0 (least skilled) - 100 (most skilled) Preschool Language Scale (PLS), Auditory Comprehension 0 (least skilled) - 100 (most skilled) Expressive Communication 0 (least skilled) - 100 (most skilled) |
| Secondary | Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine. | Baseline, 1 year | |
| Secondary | Change in RBC Folate | Baseline, 1 year |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Baseline, 1 year | Analysis per protocol | units on a scale | MEAN |
| SECONDARY | Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine. | Baseline, 1 year | analysis per protocol | mmol/L | MEAN |
| SECONDARY | Change in RBC Folate | Baseline, 1 year | Analysis per protocol | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | Bayley Scales Mental Developmental Index | 5.7 | Standard Deviation 7.8 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | Bayley Scales Psychomotor Developmental Index | 4.7 | Standard Deviation 8.6 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | VABS Communication | 5.8 | Standard Deviation 8.3 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | VABS Daily Living Skills | 3.7 | Standard Deviation 7.9 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | VABS Socialization | 4.7 | Standard Deviation 5.2 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | VABS Motor Skills | 2.0 | Standard Deviation 6.1 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | PLS Auditory Comprehension | 2.0 | Standard Deviation 10.8 | units on a scale |
| Average Change in Functioning in Specific Areas of Development, Including Speech and Communications Skills, Cognitive Abilities and Daily Living Skills | Treatment (Metafolin/Creatine/Betaine/B12) | PLS Expressive Communication | 5.5 | Standard Deviation 9.6 | units on a scale |
| Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine. | Treatment (Metafolin/Creatine/Betain/B12) | Betaine | 206.9 | Standard Deviation 224.5 | mmol/L |
| Change in Levels of Betaine, Creatine, Dimethylglycine, Guanidinoacetate, Homocysteine, and Methionine. | Treatment (Metafolin/Creatine/Betain/B12) | Creatine | 83.3 | Standard Deviation 165.9 | mmol/L |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metafolin, Betaine, Creatine, B12 Treatment | 90 | |
| Overall Study | COMPLETED | Metafolin, Betaine, Creatine, B12 Treatment | 65 | |
| Overall Study | NOT COMPLETED | Metafolin, Betaine, Creatine, B12 Treatment | 25 |
Source ClinicalTrials.gov
Adverse events12
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 | Laboratory abnormalities | General disorders | Metafolin, Betaine, Creatine, B12 Treatment | 3 | 90 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Metafolin, Betaine, Creatine, B12 Treatment | 1 | 90 | 1 |
| other | Body Odor | General disorders | Metafolin, Betaine, Creatine, B12 Treatment | 1 | 90 | 1 |
| serious | Seizure | Nervous system disorders | Metafolin, Betaine, Creatine, B12 Treatment | 18 | 90 | 18 |
| serious | Insomnia | General disorders | Metafolin, Betaine, Creatine, B12 Treatment | 14 | 90 | 14 |
| serious | Constipation | Gastrointestinal disorders | Metafolin, Betaine, Creatine, B12 Treatment | 2 | 90 | 2 |
| serious | Anorexia | Metabolism and nutrition disorders | Metafolin, Betaine, Creatine, B12 Treatment | 2 | 90 | 2 |
| serious | Increased appetite | Metabolism and nutrition disorders | Metafolin, Betaine, Creatine, B12 Treatment | 1 | 90 | 1 |
| serious | Behavior disturbance | Psychiatric disorders | Metafolin, Betaine, Creatine, B12 Treatment | 2 | 90 | 2 |
| serious | Infection | Infections and infestations | Metafolin, Betaine, Creatine, B12 Treatment | 7 | 90 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metafolin, Betaine, Creatine, B12 Treatment | ||
| Total, other adverse events | Metafolin, Betaine, Creatine, B12 Treatment | 5 | 90 |
| Total, serious adverse events | Metafolin, Betaine, Creatine, B12 Treatment | 48 | 90 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00348933
GET https://conductscience.org/api/trials/v1/NCT00348933/registered