Vitamin C And Fish Oil Together
Brief Summary:
Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Dietary Supplement: Fish Oil Dietary Supplement: Ascorbic Acid Dietary Supplement: Fish Oil Placebo Dietary Supplement: Ascorbic Acid Placebo | Phase 1 |
Detailed Description:
The aim of this study is to extend previous findings that nutritional supplementation or dietary modification can ameliorate exercise-induced bronchoconstriction. It has been shown in separate studies that fish oil and ascorbic acid (vitamin C) individually protect against EIB by improving pulmonary function and reducing airway inflammation. The main aim of this study is to determine the comparative and additive effects of fish oil and ascorbic acid supplementation on EIB and airway inflammation in asthmatic individuals.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Comparative and Additive Effects of Fish Oil and Ascorbic Acid Supplementation on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
Resource links provided by the National Library of Medicine 
| Arm | Intervention/treatment |
|---|---|
| Experimental: Active Fish Oil + Vitamin C Placebo Fifteen subjects will take 10 active fish oil capsules per day and 2 vitamin C placebo capsules per day for 3 weeks. | Dietary Supplement: Fish Oil 10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks Dietary Supplement: Ascorbic Acid Placebo 2 placebo ascorbic acid (sucrose) capsules per day for 3 weeks Other Name: Table Sugar |
| Experimental: Fish Oil Placebo + Active Vitamin C Fifteen subjects will take 10 fish oil placebo capsules per day and 2 active vitamin C capsules per day for 3 weeks. | Dietary Supplement: Ascorbic Acid 2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks Other Name: Vitamin C Dietary Supplement: Fish Oil Placebo 10 placebo fish oil (soy bean oil) capsules per day for 3 weeks Other Name: Soy Bean Oil |
| Experimental: Active Fish Oil + Active Vitamin C Following a 2-week washout period, all subjects from the other two arms (n=30) will take 10 active fish oil capsules per day and 2 active vitamin C capsules per day for 3 weeks. | Dietary Supplement: Fish Oil 10 fish oil (3.2g EPA + 2.0g DHA) capsules per day for 3 weeks Dietary Supplement: Ascorbic Acid 2 pharmaceutical grade ascorbic acid (1500mg) capsules per day for 3 weeks Other Name: Vitamin C |
Primary Outcome Measures :
- Pulmonary Function [ Time Frame: 8 weeks ]
Secondary Outcome Measures :
- Exhaled nitric oxide to measure airway inflammation [ Time Frame: 8 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
- Diagnosis of EIB, based on ≥10% fall in post-challenge FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
- Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
- Not currently taking any fish oil or ascorbic acid supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
- Agree to limit fish consumption to 1 fish meal per week throughout the study
- Agree to avoid vitamin C-rich foods throughout the study
Exclusion Criteria:
- Resting FEV1 (the amount of air blown out in the first second of a forced exhalation) <60% of predicted when off medication
- Pregnancy
- History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
- History of bleeding disorders or delayed clotting time
- History of diabetes
- History of seizures
- Allergy to fish oil or ascorbic acid (vitamin C)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057615
Locations
| United States, Indiana | |
| Indiana University | |
| Bloomington, Indiana, United States, 47405 | |
Sponsors and Collaborators
Indiana University
Investigators
| Study Director: | Timothy D Mickleborough, PhD | Indiana University |
Publications:
| Responsible Party: | Timothy Mickleborough, PhD / Associate Professor, Indiana University |
| ClinicalTrials.gov Identifier: | NCT01057615 |
| Other Study ID Numbers: | 0910000751 |
| First Posted: | January 27, 2010 Key Record Dates |
| Last Update Posted: | January 31, 2011 |
| Last Verified: | January 2011 |
Keywords provided by Indiana University:
| Asthma Exercise-Induced Bronchoconstriction Inflammation | Airway Fish Oil Ascorbic Acid |
Additional relevant MeSH terms:
| Asthma Inflammation Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity | Immune System Diseases Pathologic Processes Ascorbic Acid Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Vitamin C And Fish Oil Together
Source: https://clinicaltrials.gov/ct2/show/NCT01057615#:~:text=Combining%20fish%20oil%20and%20vitamin,than%20either%20nutritional%20supplement%20alone.
