C-reactive ProteinPhase 3NCT01028976
Obesity, Inflammation and Oxidative Stress
A Phase 3 study testing Vitamin C (ascorbic acid) in people with C-reactive Protein and Inflammation, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- C-reactive Protein, Inflammation, Obesity
- What is being tested?
- Vitamin C (ascorbic acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 30
- hsCRP ≥ 1 mg/L
- Age 18+
- Member of Kaiser Permanente Health Plan of Northern California
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente of Northern California, Division of Research
Oakland, California, 94612
About this study
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.
Read the detailed description
The long-term objective of this project is to identify nutritional factors that can reduce the inflammatory component of obesity. Therapies to minimize obesity-related comorbidities are needed, and targeting inflammation may help slow the progression of obesity towards cardiovascular disease and insulin resistance.
Adipose tissue is a source of inflammatory cytokines, and obesity is now viewed as a chronic, low-grade inflammatory state. Inflammation itself is a contributor to the chronic diseases associated with obesity. C-reactive protein (CRP) is a key marker of inflammation, and as a downstream marker it provides functional integration of upstream cytokine activation associated with inflammation. We have previously shown that vitamin C, but not vitamin E, reduces CRP in active and passive smokers and in nonsmokers. The reduction is seen primarily in persons with CRP ≥1.0 mg/L, the CDC threshold for elevated cardiovascular disease risk. We also found that 75% of obese nonsmokers had CRP ≥1.0 mg/L.
The important observation of reduction in elevated CRP by vitamin C now needs to be confirmed in a rigorous study with adequate sample size, to permit justifiable conclusions about the potential usefulness of this agent in reducing inflammation in the obese. We will conduct a placebo-controlled, randomized trial in 552 healthy obese individuals with moderate CRP elevations (CRP ≥1.0 mg/L). Participants will be randomized to either 1000 mg/day vitamin C or placebo for a period of 2 months. We will also characterize the pathways through which this effect takes place by measuring cytokines and oxidative stress.
This project is important because if our previous finding is confirmed in this population, it could offer a low-cost alternative to use of statins to reduce inflammation in persons without other risk factors.
- Conditions
- C-reactive Protein, Inflammation, Obesity, Oxidative Stress
- Being tested
- Vitamin C (ascorbic acid), Placebo tablet
- Keywords
- randomized controlled trial, primary prevention, Vitamin C, Antioxidants, C-reactive protein, inflammation, anti-inflammatory agents, obesity
- Medical subject headings
- Inflammation, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C (ascorbic acid)Dietary supplement
1000 mg/day (two 500-mg tablets), 8 weeks
Placebo tabletDietary supplement
Placebo tablet (two 500-mg tablets), 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Two tablets, daily, for 8 weeks Receives: Dietary Supplement: Placebo tablet |
| Vitamin C | Experimental | Two tablets, daily, for 8 weeks Receives: Dietary Supplement: Vitamin C (ascorbic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-sensitivity C-reactive protein
Measured: After 8 weeks of intervention
Secondary outcomes (1)
CRP-related markers of inflammation and oxidative stress, including cytokines and F2-isoprostanes.
Measured: After 8 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for C-reactive ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Principal investigator, Gladys Block, University of California, Berkeley
- Investigators
- Gladys Block, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028976
- Sponsor's protocol ID
- DK062378-05
- Status last verified
- Nov 2015
- First submitted
- 8 Dec 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18952164Block 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.
PubMed 15047680
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, Inflammation and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01028976
- Acronym / sponsor ID
- DK062378-05
- Conditions
- C-reactive Protein, Inflammation, Obesity, Oxidative Stress
- Keywords
- randomized controlled trial, primary prevention, Vitamin C, Antioxidants, C-reactive protein, inflammation, anti-inflammatory agents, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long-term objective of this project is to identify nutritional factors that can reduce the inflammatory component of obesity. Therapies to minimize obesity-related comorbidities are needed, and targeting inflammation may help slow the progression of obesity towards cardiovascular disease and insulin resistance.
Adipose tissue is a source of inflammatory cytokines, and obesity is now viewed as a chronic, low-grade inflammatory state. Inflammation itself is a contributor to the chronic diseases associated with obesity. C-reactive protein (CRP) is a key marker of inflammation, and as a downstream marker it provides functional integration of upstream cytokine activation associated with inflammation. We have previously shown that vitamin C, but not vitamin E, reduces CRP in active and passive smokers and in nonsmokers. The reduction is seen primarily in persons with CRP ≥1.0 mg/L, the CDC threshold for elevated cardiovascular disease risk. We also found that 75% of obese nonsmokers had CRP ≥1.0 mg/L.
The important observation of reduction in elevated CRP by vitamin C now needs to be confirmed in a rigorous study with adequate sample size, to permit justifiable conclusions about the potential usefulness of this agent in reducing inflammation in the obese. We will conduct a placebo-controlled, randomized trial in 552 healthy obese individuals with moderate CRP elevations (CRP ≥1.0 mg/L). Participants will be randomized to either 1000 mg/day vitamin C or placebo for a period of 2 months. We will also characterize the pathways through which this effect takes place by measuring cytokines and oxidative stress.
This project is important because if our previous finding is confirmed in this population, it could offer a low-cost alternative to use of statins to reduce inflammation in persons without other risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo tabletTwo tablets, daily, for 8 weeks |
| Vitamin C | Experimental | Dietary Supplement: Vitamin C (ascorbic acid)Two tablets, daily, for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 30
- hsCRP ≥ 1 mg/L
- Age 18+
- Member of Kaiser Permanente Health Plan of Northern California
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C (ascorbic acid)1000 mg/day (two 500-mg tablets), 8 weeks | Dietary supplement | Vitamin C |
| Placebo tabletPlacebo tablet (two 500-mg tablets), 8 weeks | Dietary supplement | Placebo |
Primary outcome
high-sensitivity C-reactive protein
Time frame: After 8 weeks of intervention
1 secondary outcome
CRP-related markers of inflammation and oxidative stress, including cytokines and F2-isoprostanes.
Time frame: After 8 weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 18952164Block 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.
- Background: PubMed 15047680Block 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gladys Block, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C (ascorbic acid) in people with C-reactive Protein and Inflammation, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-sensitivity C-reactive protein (time frame: After 8 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028976, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.