Trial · NCT01550705
Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria
NCT01550705, Not applicable, Terminated, University of Utah; results first posted 2017-01-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria. Trials, record NCT01550705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01550705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Isoniazid on Protoporphyrin Levels in Erythropoietic Protoporphyria
- NCT number
- NCT01550705
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 11 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Erythropoietic Protoporphyria (EPP), X Linked Erythropoietic Protoporphyria
- Interventions
- Isoniazid
- First posted
- 2012-03-12
- Last updated
- 2017-01-16
- Results first posted
- 2017-01-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Plasma Protoporphyrin IX Level | Baseline and 3 Months | Plasma Protoporphyrin IX will be measured at baseline and at 3 months |
| Secondary | Participants With Increased Sun Sensitivity | Baseline and 3 Months | Study participants were asked to report after 3 months if they had experienced an increase in subjective measures of sun sensitivity during the trial. Reported outcome is the number of study participants who reported increased sun sensitivity |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Plasma Protoporphyrin IX Level | Baseline and 3 Months | µg/dL | MEAN | |
| SECONDARY | Participants With Increased Sun Sensitivity | Baseline and 3 Months | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Change in Plasma Protoporphyrin IX Level | Isoniazid | 0.36 | Standard Deviation 9.1 | µg/dL | |
| Participants With Increased Sun Sensitivity | Isoniazid | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Isoniazid | 11 | |
| Overall Study | COMPLETED | Isoniazid | 10 | |
| Overall Study | NOT COMPLETED | Isoniazid | 1 |
Source ClinicalTrials.gov
Adverse events9
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 | Constipation | Gastrointestinal disorders | Isoniazid | 1 | 11 | 1 |
| other | Productive Cough | Respiratory, thoracic and mediastinal disorders | Isoniazid | 1 | 11 | 1 |
| other | Urinary Tract Pain | Renal and urinary disorders | Isoniazid | 1 | 11 | 1 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Isoniazid | 1 | 11 | 2 |
| other | Headache | Nervous system disorders | Isoniazid | 1 | 11 | 1 |
| other | Atrial Flutter | Cardiac disorders | Isoniazid | 1 | 11 | 1 |
| other | Dysmenorrhea | Reproductive system and breast disorders | Isoniazid | 1 | 11 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Isoniazid | 1 | 11 | 1 |
| serious | Flu-like Symptoms | General disorders | Isoniazid | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Isoniazid | ||
| Total, other adverse events | Isoniazid | 5 | 11 |
| Total, serious adverse events | Isoniazid | 1 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U54DK083909 | Porphyrias Consortium | DESNICK, ROBERT J; BALWANI, MANISHA | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2009 to 2023 |
Source NIH RePORTER
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/NCT01550705
GET https://conductscience.org/api/trials/v1/NCT01550705/registered