NCT03889158

Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation

Terminated Phase 4 Results posted Last updated 12 November 2021

What this trial tests

Phase 4 trial testing Typhoid Vaccine in Aging in 35 participants. Terminated before completion.

Timeline

25 March 2019

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	35
Start date	25 March 2019
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Typhoid Vaccine — full drug profile →
• Ascorbic Acid (ASCORBIC ACID) — full drug profile →

Conditions studied

• Aging — all drugs for Aging →
• Inflammation — all drugs for Inflammation →

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 75, any sex, with Aging or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Endothelial Function Primary · Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]

Flow-mediated dilation - Brachial artery vasodilator function will be noninvasively measured through assessment of brachial artery dilation using ultrasonography. The brachial artery will be imaged proximal to placement of a blood pressure cuff just below the antecubital fossa. Endothelium-dependent dilation of the brachial artery will be measured at baseline and again for 5 minutes following ischemic stimulus (inflation of a blood pressure cuff around the forearm to 250 mmHg for 5 minutes).

Baseline

Group	Value	95% CI
Older Adults	2.4	± 1.8
Younger Adults	5.5	± 3.4

Baseline + Vit C

Group	Value	95% CI
Older Adults	3.4	± 2.7
Younger Adults	5.7	± 3.0

Pre-Inflammation Baseline

Group	Value	95% CI
Older Adults	3.4	± 1.9
Younger Adults	6.3	± 3.3

Inflammation

Group	Value	95% CI
Older Adults	1.6	± 1.7
Younger Adults	5.8	± 3.4

Inflammation + Vit C

Group	Value	95% CI
Older Adults	2.8	± 1.9
Younger Adults	6.1	± 3.2

Change in Oxidative Stress Primary · Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]

Oxidized low-density lipoprotein, vitamin C and total antioxidant capacity will be assessed using standard ELISAs from a venous blood draw. The analyses of the oxidized LDL and total antioxidant capacity failed. Only data on Vitamin C are presented.

Baseline

Group	Value	95% CI
Older Adults	6.2	± 1.2
Younger Adults	4.7	± 2.1

Baseline + Vit C

Group	Value	95% CI
Older Adults	13.3	± 2.1
Younger Adults	11.7	± 2.9

Pre-Inflammation

Group	Value	95% CI
Older Adults	5.8	± 1.1
Younger Adults	5.4	± 1.2

Inflammation

Group	Value	95% CI
Older Adults	6.6	± 1.1
Younger Adults	7.2	± 4.1

Inflammation + Vit C

Group	Value	95% CI
Older Adults	13.4	± 3.1
Younger Adults	13.3	± 3.0

Change in Arterial Stiffness Secondary · Visit 1: At [BASELINE] and 2 hours following Vit C [BASELINE+VIT C]; Visit 2 (>72 hours after Visit 1): At baseline [PRE-INFLAMMATION BASELINE]; Visit 3 (24 hours after Visit 2): At baseline [INFLAMMATION] and 2 hours following Vit C [INFLAMMATION+VIT C]

Central pulse wave velocity - Approximately 20-sec of pressure waveforms will be collected at the brachial, common carotid, and femoral arteries using a high-fidelity strain-gauge transducer. Pulse wave velocity will be calculated from the distances between measurement points and the measured time delay between proximal (carotid) and distal (femoral) waveforms.

Baseline

Group	Value	95% CI
Older Adults	9.3	± 2.0
Younger Adults	5.8	± .8

Baseline + Vit C

Group	Value	95% CI
Older Adults	9.9	± 3.0
Younger Adults	5.9	± .9

Pre-inflammation

Group	Value	95% CI
Older Adults	8.8	± 2.1
Younger Adults	5.6	± .4

Inflammation

Group	Value	95% CI
Older Adults	8.8	± 1.7
Younger Adults	5.6	± .6

Inflammation + Vit C

Group	Value	95% CI
Older Adults	8.9	± 2.1
Younger Adults	5.7	± .5

Sponsor's own description

This study focuses on whether high cardiorespiratory fitness in older adults has a protective effect on the vascular response to acute inflammation in comparison to low-fit older and young adults.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.