Trial · NCT00696410
The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy
NCT00696410, Phase 1, Completed, University of Michigan; results first posted 2017-10-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy. Trials, record NCT00696410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00696410
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Zinc Supplementation on Left Ventricular Function in Nonischemic Cardiomyopathy
- NCT number
- NCT00696410
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Heart Failure, Cardiomyopathies
- Interventions
- Zinc Acetate
- First posted
- 2008-06-12
- Last updated
- 2017-11-06
- Results first posted
- 2017-10-04
- Limitations and caveats
Zinc acetate was poorly tolerated by some patients. Patients often commented on GI upset (nausea) and reflux symptoms at follow-up encounter. The myeloperoxidase assay demonstrated marked variability and test validity/quality is in question.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls. | Baseline (time 0) and after 10 months of Zinc Acetate. | The intervention group (patients with systolic heart failure) was given Zinc Acetate 50 mg po three times daily for 10 months. The change from baseline in markers of cardiac collagen turnover (PINP) in patients with systolic heart failure after 10 months of zinc acetate was measured and compared with a single measure from healthy controls. |
| Secondary | Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure | Baseline (time 0) and 10 months | Change from baseline in serum isoprostane 10 months after Zn Acetate in patients with systolic heart failure and compared with a single measure in healthy subjects |
| Other | Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls | Baseline (time 0) and 10 months | Change in PIIINP from baseline after 10 months of Zinc Acetate in patients with systolic heart failure and compared with a single measure in healthy controls |
| Other | Change From Baseline in Serum Superoxide Dismutase | Baseline (time 0) and 10 months | Change from baseline in serum superoxide dismutase after 10 months of zinc acetate in patients with systolic heart failure and compared with a single measure in healthy controls |
| Other | Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment | Baseline (time 0) and 10 months | Change from baseline in serum myeloperoxidase (MPO) after 10 months of zinc acetate treatment in patients with systolic heart failure and compared with a single measure from healthy controls |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls. | Baseline (time 0) and after 10 months of Zinc Acetate. | Power was determined using prior studies examining the change in PINP and (separately) PIIINP in heart failure following administration of aldactone. Results below are PINP. For Controls, a single measure was obtained without further followup. | ng/ml | MEDIAN |
| SECONDARY | Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure | Baseline (time 0) and 10 months | power calculation using prior studies of the above laboratories. For Controls, a single measure was obtained without further followup. | pg/ml | MEDIAN |
| OTHER_PRE_SPECIFIED | Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls | Baseline (time 0) and 10 months | Specimens from healthy controls were only analyzed at one time frame. | ng/ml | MEDIAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Serum Superoxide Dismutase | Baseline (time 0) and 10 months | Specimens from healthy controls were only analyzed at one time frame. | units per microL | MEDIAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Serum Measures of of Myeloperoxidase (MPO) After 10 Months of Zinc Acetate Treatment | Baseline (time 0) and 10 months | Healthy controls only analyzed at one time point | units per L | MEDIAN |
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 |
|---|---|---|---|---|---|
| Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls. | CHF Patients With Zinc Acetate | PINP baseline (time 0) | 48.1 | Inter-Quartile Range 41.6 to 68 | ng/ml |
| Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls. | Healthy Controls | PINP baseline (time 0) | 48.1 | Inter-Quartile Range 41.6 to 59.4 | ng/ml |
| Change From Baseline in Markers of Cardiac Collagen Turnover (PINP) in Patients With Systolic Heart Failure and Compared With Healthy Controls. | CHF Patients With Zinc Acetate | PINP after 10 mo therapy | 39 | Inter-Quartile Range 31 to 53 | ng/ml |
| Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure | CHF Treated With Zinc Acetate | Isoprostane baseline | 4.4 | Inter-Quartile Range 3.4 to 5.3 | pg/ml |
| Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure | Health Controls | Isoprostane baseline | 3.8 | Inter-Quartile Range 3.1 to 5.2 | pg/ml |
| Change From Baseline in Serum Isoprostane in Patients With Systolic Heart Failure | CHF Treated With Zinc Acetate | Isoprostane 10 mo | 4.4 | Inter-Quartile Range 3.3 to 5.3 | pg/ml |
| Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls | CHF Patients With Zinc Acetate | PIIINP baseline | 5.3 | Inter-Quartile Range 4.1 to 6.1 | ng/ml |
| Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls | Healthy Controls | PIIINP baseline | 4.1 | Inter-Quartile Range 3.1 to 4.5 | ng/ml |
| Change in PIIINP From Baseline After 10 Months of Zinc Acetate in Systolic Heart Failure and Compared With a Single Measure in Healthy Controls | CHF Patients With Zinc Acetate | PIIINP 10 months | 5.3 | Inter-Quartile Range 2.6 to 9 | ng/ml |
| Change From Baseline in Serum Superoxide Dismutase | CHF Treated With Zinc Acetate | SOD at Baseline | 160 | Inter-Quartile Range 88 to 261 | units per microL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zinc Acetate | 38 | |
| Overall Study | STARTED | Control | 10 | |
| Overall Study | COMPLETED | Zinc Acetate | 25 | |
| Overall Study | COMPLETED | Control | 10 | |
| Overall Study | NOT COMPLETED | Zinc Acetate | 13 | |
| Overall Study | NOT COMPLETED | Control | 0 |
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 | dizziness | Nervous system disorders | HF Group | 1 | 38 | 2 |
| other | dizziness | Nervous system disorders | Healthy Controls | 0 | 10 | 0 |
| other | Odd taste in mouth | General disorders | HF Group | 1 | 38 | 2 |
| other | Odd taste in mouth | General disorders | Healthy Controls | 0 | 10 | 0 |
| other | Nausea | Gastrointestinal disorders | HF Group | 6 | 38 | 6 |
| other | Nausea | Gastrointestinal disorders | Healthy Controls | 0 | 10 | 0 |
| serious | Intracoronary stent | Cardiac disorders | HF Group | 1 | 38 | 3 |
| serious | Intracoronary stent | Cardiac disorders | Healthy Controls | 0 | 10 | 0 |
| serious | Nonelective Hospitalization- accident | Injury, poisoning and procedural complications | HF Group | 1 | 38 | 3 |
| serious | Nonelective Hospitalization- accident | Injury, poisoning and procedural complications | Healthy Controls | 0 | 10 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HF Group | 0 | 38 |
| Total, all-cause mortality | Healthy Controls | 0 | 10 |
| Total, other adverse events | HF Group | 6 | 38 |
| Total, other adverse events | Healthy Controls | 0 | 10 |
| Total, serious adverse events | HF Group | 3 | 38 |
| Total, serious adverse events | Healthy Controls | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HF Group vs Healthy Controls: deaths from any cause | Trial comparisons |
| HF Group vs Healthy Controls: serious adverse events | 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/NCT00696410
GET https://conductscience.org/api/trials/v1/NCT00696410/registered