NCT01028976

Brief Summary

The purpose of this study is to determine whether or not Vitamin C (1000 mg/day) can reduce markers of inflammation, especially C-reactive protein (CRP), in obese persons with baseline CRP greater than 1 mg/dl.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

December 8, 2009

Last Update Submit

November 30, 2015

Conditions

C-reactive ProteinInflammationObesityOxidative Stress

Keywords

randomized controlled trialprimary preventionVitamin CAntioxidantsC-reactive proteininflammationanti-inflammatory agentsobesity

Outcome Measures

Primary Outcomes (1)

  • high-sensitivity C-reactive protein

    After 8 weeks of intervention

Secondary Outcomes (1)

  • CRP-related markers of inflammation and oxidative stress, including cytokines and F2-isoprostanes.

    After 8 weeks of intervention.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Two tablets, daily, for 8 weeks

Dietary Supplement: Placebo tablet

Vitamin C

EXPERIMENTAL

Two tablets, daily, for 8 weeks

Dietary Supplement: Vitamin C (ascorbic acid)

Interventions

Vitamin C (ascorbic acid)DIETARY_SUPPLEMENT

1000 mg/day (two 500-mg tablets), 8 weeks

Vitamin C
Placebo tabletDIETARY_SUPPLEMENT

Placebo tablet (two 500-mg tablets), 8 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 30
  • hsCRP ≥ 1 mg/L
  • Age 18+
  • Member of Kaiser Permanente Health Plan of Northern California

You may not qualify if:

  • Smoker
  • Unwilling to discontinue vitamin supplements for study duration
  • Unwilling/unable to use acetaminophen in place of OTC anti-inflammatory medications
  • Use of certain medications
  • History of certain medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente of Northern California, Division of Research

Oakland, California, 94612, United States

Location

Related Publications (2)

  • Block G, Jensen CD, Dalvi TB, Norkus EP, Hudes M, Crawford PB, Holland N, Fung EB, Schumacher L, Harmatz P. Vitamin C treatment reduces elevated C-reactive protein. Free Radic Biol Med. 2009 Jan 1;46(1):70-7. doi: 10.1016/j.freeradbiomed.2008.09.030. Epub 2008 Oct 10.

    PMID: 18952164BACKGROUND

  • Block G, Jensen C, Dietrich M, Norkus EP, Hudes M, Packer L. Plasma C-reactive protein concentrations in active and passive smokers: influence of antioxidant supplementation. J Am Coll Nutr. 2004 Apr;23(2):141-7. doi: 10.1080/07315724.2004.10719354.

    PMID: 15047680BACKGROUND

MeSH Terms

Conditions

InflammationObesity

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Gladys Block, PhD

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emerita

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

January 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)