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Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD) (Quercetin)

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ClinicalTrials.gov Identifier: NCT01708278
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Quercegen Pharmaceuticals
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Umadevi S. Sajjan, University of Michigan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Quercetin
Other: Placebo - sugar chew

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sugar Chew- Cohort 1

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin 1-Cohort 1

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2-Cohort 2

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 3-Cohort 3

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Sugar Chew-Cohort 2

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Sugar Chew-Cohort 3

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)


Participant Flow:   Overall Study
    Sugar Chew- Cohort 1   Quercetin 1-Cohort 1   Quercetin 2-Cohort 2   Quercetin 3-Cohort 3   Sugar Chew-Cohort 2   Sugar Chew-Cohort 3
STARTED   1   2   2   2   1   1 
COMPLETED   1   2   2   2   1   1 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Chew- Cohort 1

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin 1-Cohort 1

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2-Cohort 2

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 3-Cohort 3

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Sugar Chew-Cohort 2

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Sugar Chew-Cohort 3

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Total Total of all reporting groups

Baseline Measures
   Sugar Chew- Cohort 1   Quercetin 1-Cohort 1   Quercetin 2-Cohort 2   Quercetin 3-Cohort 3   Sugar Chew-Cohort 2   Sugar Chew-Cohort 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   2   2   2   1   1   9 
Age, Customized 
[Units: Participants]
             
Age 40 - 80 years   1   2   2   2   1   1   9 
Gender 
[Units: Participants]
Count of Participants
             
Female      1 100.0%      1  50.0%      0   0.0%      1  50.0%      1 100.0%      0   0.0%      4  44.4% 
Male      0   0.0%      1  50.0%      2 100.0%      1  50.0%      0   0.0%      1 100.0%      5  55.6% 
Region of Enrollment 
[Units: Participants]
             
United States   1   2   2   2   1   1   9 
Lung Function [1] 
[Units: Participants]
 1   2   2   2   1   1   9 


  Outcome Measures

1.  Primary:   Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description   [ Time Frame: One week in Phase I safety study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Fernando Martinez
Organization: University of Michigan
phone: (734) 763-2540
e-mail: fmartine@umich.edu


Publications:


Responsible Party: Umadevi S. Sajjan, University of Michigan
ClinicalTrials.gov Identifier: NCT01708278     History of Changes
Obsolete Identifiers: NCT02013440
Other Study ID Numbers: HUM00061735
R21AT007357 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2012
First Posted: October 16, 2012
Results First Submitted: October 31, 2016
Results First Posted: December 26, 2016
Last Update Posted: December 26, 2016