Vitamin C to Reduce Morning Cardiovascular Risk

NCT03290612 | Completed

• 1 other identifier: IRB 00017294
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the efficacy of Vitamin C to counteract morning cardiovascular (CV) risk markers in a randomized, double blind, placebo controlled crossover pilot study. The participants will also perform morning typical behaviors such as arousal from sleep, change in posture (getting out of bed) and mild intensity physical activity; identical to the stressors encountered in everyday life. Primary dependent variables are markers of cardiovascular risk including vascular endothelial function and oxidative stress.

Conditions

Cardiovascular Risk Factor

Keywords

Sleep; Vitamin C

Outcome Measures

Primary Outcomes (3)

• Vascular Endothelial Function

  Vascular endothelial function will be measured as flow-mediated dilation (FMD). We will measure brachial artery FMD immediately upon awakening in a constant posture following an overnight fast using the standard guidelines and protocol.

  Approximately three months

• Oxidative stress

  Oxidative stress will be measured as malondialdehyde (MDA) adducts from Ethylenediaminetetraacetic acid (EDTA) plasma. Higher values may indicate increased oxidative stress.

  Approximately three months

• Plasma Vitamin C and Tetrahydrobiopterin

  We will measure Vitamin C levels in the plasma to ensure that the levels are increased after supplementation, and to control for baseline levels. We will measure tetrahydrobiopterin (BH4) from plasma to test if levels are increased upon administration of Vitamin C.

  Approximately three months

Secondary Outcomes (2)

• Platelet aggregation

  Approximately three months

• Plasminogen activator inhibitor -1

  Approximately three months

Study Arms (2)

Vitamin C then Placebo

EXPERIMENTAL

Participants will receive a 1.5g dose of Ascorbic Acid upon wake for the first visit, and a placebo tablet on the second visit.

Dietary Supplement: Vitamin C; Other: Placebo

Placebo then Vitamin C

EXPERIMENTAL

Participants will receive a placebo tablet upon wake for the first visit, and a 1.5g dose of Ascorbic Acid on the second visit.

Dietary Supplement: Vitamin C; Other: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

1.5g Ascorbic Acid

Also known as: Ascorbic Acid

Placebo then Vitamin C; Vitamin C then Placebo

Placebo OTHER

Inactive placebo to mimic 1.5g ascorbic acid.

Placebo then Vitamin C; Vitamin C then Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants
• Normal weight or overweight but not obese (18.5\<BMI\<33 kg/m2)

You may not qualify if:

• History of smoking/tobacco use
• Current prescription/non-prescription medications or drugs of abuse
• Acute, chronic, or debilitating medical conditions
• History of working irregular day and night hours, regular night work, or rotating shift work for the six months prior to the study.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Saurabh S Thosar, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vitamin C and Placebo doses will be blinded by the research pharmacy, so that participants and investigators are masked to the identity of the tablet. Data analysis will be blinded to the conditions as well until the completion of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Oregon Institute of Occupational Health Sciences

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 25, 2017
• Study Start: February 13, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)