Trial · NCT00283387
Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria
NCT00283387, Phase 2, Completed, Mayo Clinic; results first posted 2013-01-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria. Trials, record NCT00283387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00283387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria
- NCT number
- NCT00283387
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Hyperoxaluria
- Interventions
- Betaine, Placebo
- First posted
- 2006-01-27
- Last updated
- 2013-12-16
- Results first posted
- 2013-01-01
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urinary Oxalate Excretion | baseline, 2 months, 6 months | The patients were randomly assigned oral betaine or placebo for 2 months, followed by a 2 month washout. Each patient then received the alternate study medication for 2 months. Urinary Oxalate Excretion was measured by oxalate oxidase. Two 24 hour urine collections were obtained at baseline, and during the eighth week of each study period. |
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 | Urinary Oxalate Excretion | baseline, 2 months, 6 months | Per protocol analysis: 10 of 15 enrolled PHI subjects completed the study: 2 withdrew before initiation, 2 were noncompliant, in 1 symptoms led to withdrawal. | umol/mg | 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 |
|---|---|---|---|---|---|
| Urinary Oxalate Excretion | Betaine | 1.43 | Standard Deviation 0.97 | umol/mg | |
| Urinary Oxalate Excretion | Placebo | 1.04 | Standard Deviation 0.71 | umol/mg |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Betaine First, Then Placebo | 6 | |
| First Intervention | STARTED | Placebo First, Then Betaine | 7 | |
| First Intervention | COMPLETED | Betaine First, Then Placebo | 5 | |
| First Intervention | COMPLETED | Placebo First, Then Betaine | 5 | |
| First Intervention | NOT COMPLETED | Betaine First, Then Placebo | 1 | |
| First Intervention | NOT COMPLETED | Placebo First, Then Betaine | 2 | |
| Washout Period of 2 Months | STARTED | Betaine First, Then Placebo | 5 | |
| Washout Period of 2 Months | STARTED | Placebo First, Then Betaine | 5 | |
| Washout Period of 2 Months | COMPLETED | Betaine First, Then Placebo | 5 | |
| Washout Period of 2 Months | COMPLETED | Placebo First, Then Betaine | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events8
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 | Dyspepsia | Gastrointestinal disorders | Betaine | 10 | 13 | 10 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 7 | 13 | 7 |
| other | Diarrhea/loose stools | Gastrointestinal disorders | Betaine | 6 | 13 | 6 |
| other | Diarrhea/loose stools | Gastrointestinal disorders | Placebo | 6 | 13 | 6 |
| other | Constipation | Gastrointestinal disorders | Betaine | 2 | 13 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 13 | 1 |
| other | Headache | General disorders | Betaine | 4 | 13 | 4 |
| other | Headache | General disorders | Placebo | 1 | 13 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Betaine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Betaine | 11 | 13 |
| Total, other adverse events | Placebo | 8 | 13 |
| Total, serious adverse events | Betaine | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 13 |
Source ClinicalTrials.gov
Papers29
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01DK073354 | Prevention of Renal Damage in Primary Hyperoxaluria | MILLINER, DAWN SCHMAUTZ | MAYO CLINIC ROCHESTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2005 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Betaine 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/NCT00283387
GET https://conductscience.org/api/trials/v1/NCT00283387/papers?page=2