Trial · NCT01566084
Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults
NCT01566084, Not applicable, Completed, University of Colorado, Boulder; results first posted 2014-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults. Trials, record NCT01566084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01566084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Dietary Sodium Restriction of Improving Vascular Endothelial Function in Middle Aged and Older Adults
- NCT number
- NCT01566084
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- University of Colorado, Boulder
- Conditions
- Hypertension
- Interventions
- Slow sodium tablets, placebo
- First posted
- 2012-03-29
- Last updated
- 2016-01-07
- Results first posted
- 2014-06-20
- Limitations and caveats
- Due to the complexity, burden, and, in some cases, invasiveness of the study design and procedures, only a limited number of subjects could be studied.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improved Flow Mediated Dilation | Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first) | FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks. |
| Secondary | Vascular Oxidative Stress | Immediately following acute infusion of ascorbic acid on Weeks 5 and 10 | Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative. |
| Secondary | BH4 Bioavailability | Immediately following acute administration of BH4 on Weeks 5 and 10 | Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability. |
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 | Improved Flow Mediated Dilation | Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first) | All subjects are analyzed under each condition because of the cross-over design. | percentage dilation | MEAN |
| SECONDARY | Vascular Oxidative Stress | Immediately following acute infusion of ascorbic acid on Weeks 5 and 10 | Ascorbic acid is missing in one participant due to a failed i.v. | percentage dilation | MEAN |
| SECONDARY | BH4 Bioavailability | Immediately following acute administration of BH4 on Weeks 5 and 10 | BH4 could not be administered to 3 participants due to canceled visits. | percentage dilation | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Improved Flow Mediated Dilation | Normal Sodium Diet | 3.57 | Standard Deviation 1.59 | percentage dilation | |
| Improved Flow Mediated Dilation | Low Sodium Diet. | 6.01 | Standard Deviation 2.31 | percentage dilation | |
| Vascular Oxidative Stress | Normal Sodium Saline | 3.57 | Standard Deviation 1.69 | percentage dilation | |
| Vascular Oxidative Stress | Low Sodium Saline | 6.01 | Standard Deviation 2.31 | percentage dilation | |
| Vascular Oxidative Stress | Normal Sodium Ascorbic Acid | 4.90 | Standard Deviation 2.84 | percentage dilation | |
| Vascular Oxidative Stress | Low Sodium Ascorbic Acid | 5.51 | Standard Deviation 2.36 | percentage dilation | |
| BH4 Bioavailability | Normal Sodium Placebo | 3.57 | Standard Deviation 1.69 | percentage dilation | |
| BH4 Bioavailability | Low Sodium Placebo | 6.01 | Standard Deviation 2.31 | percentage dilation | |
| BH4 Bioavailability | Normal Sodium BH4 | 5.78 | Standard Deviation 2.02 | percentage dilation | |
| BH4 Bioavailability | Low Sodium BH4 | 6.11 | Standard Deviation 2.32 | percentage dilation |
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 | Slow Sodium Tablets (Start) | 7 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | Slow Sodium Tablets (Start) | 7 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | Slow Sodium Tablets (Start) | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Normal Sodium | ||
| Total, all-cause mortality | Low Sodium | ||
| Total, other adverse events | Normal Sodium | 0 | 17 |
| Total, other adverse events | Low Sodium | 0 | 17 |
| Total, serious adverse events | Normal Sodium | 0 | 17 |
| Total, serious adverse events | Low Sodium | 0 | 17 |
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 |
|---|---|---|---|---|---|
| F31AG033994 | Vascular Endothelial Dysfunction in Older Adults: Dietary Sodium Restriction | NOWAK, KRISTEN LYNN | UNIVERSITY OF COLORADO | NATIONAL INSTITUTE ON AGING | 2009 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Normal Sodium vs Low Sodium: 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/NCT01566084
GET https://conductscience.org/api/trials/v1/NCT01566084/registered