| Sponsored by: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00924547 |
Purpose Oral supplementation of patients affected by cystic fibrosis with docosahexanoic acid (DHA) will result in normalization of the known fatty acid derangements in these patients and will diminish the production of proinflammatory isoprostanes such as 8-isoprostane-PGF2α.
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Dietary Supplement: Docosahexanoic Acid Supplement Dietary Supplement: Placebo | Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-Inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma |
- Exhaled breath 8-isoprostane-PGFα [ Time Frame: 4 measurements: baseline, 4 weeks, after a 2-4 week washout, and 4 weeks later ] [ Designated as safety issue: No ]
- Fatty acid profile analysis including esterification sites in plasma [ Time Frame: 4 measurements - Baseline, 4 weeks, 2-4 weeks later, and 4 weeks after that ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 18 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Docosahexanoic Acid Supplement: Experimental | Dietary Supplement: Docosahexanoic Acid Supplement The active treatment will consist of Martek's chewable DHA capsules containing 200mg in each capsule. The treatment will be provided as approximately 35mg/kg/day. The dosing is as follows: Patient weight (kg) 35mg/kg/day dose 20-24kg: 800mg 25-34kg: 1000mg 35-44kg: 1400mg 45-54kg: 1800mg 55-64kg: 2200mg 65-74kg: 2400mg 75+kg: 2600mg These dosages will be divided BID-TID and will be given for 4 weeks. |
| Placebo: Placebo Comparator | Dietary Supplement: Placebo Placebo identical to active treatment. |
Detailed Description:
The study design will be a single-center, randomized, placebo-controlled, cross-over trial. After informed consent has been obtained, 18 eligible subjects with pancreatic insufficient cystic fibrosis will be enrolled in the study. Participants will take part in two 4 week study sessions, each separated by a 2-4 week washout period. One session will involve treatment with placebo and one will provide treatment with approximately 35 mg of DHA/kg of body weight (maximum dose 3 g/day. The patients will be assigned to each of the treatment sessions in random order, as described above. The DHA source will be provided by Martek Biosciences Corporation, Columbia, MD, USA in the form of a chewable capsule containing 200 mg of DHA. The placebos will be identical to the DHA supplement but will not contain the active ingredient, DHA. Subjects will be instructed to take the study capsules in addition to their normal doses of pancreatic enzymes with meals and to maintain their usual diets. Blood, urine, and exhaled breath condensate samples will be collected at baseline, after completion of the first session, after the washout period, and after the completion of the second session. Patients will be screened and enrolled when they present to clinic for their routine check-up. The subjects have routine blood work at their annual check-ups, and when possible will have an additional tube of blood saved for the baseline fatty acid profiles so as to avoid unnecessary blood draws. The patients will be scheduled for a visit to the CRC to complete the baseline data gathering, submit a urine sample, and complete an exhaled breath collection (EBC).
The subjects will complete a clinical questionnaire administered by the study PI to evaluate their health and diet. The patients will also be given the supply of DHA of placebo for their first session at that Visit 1. The order in which they take the supplement or the placebo will be determined using a randomization table provided by Li Wang, the biostatistician working with this study.
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Cystic Fibrosis based on sweat chloride value > 60 mEq/L or genotyping
- Pancreatic insufficiency, defined by requirement for treatment with exogenous pancreatic enzymes
- FEV 1 > 40
- Less than 3 pulmonary exacerbations in the last year (as diagnosed by pulmonary attending physician)
- Age greater than 6 years
- Capability of performing pulmonary function tests
- Ability to swallow gel capsule
- Ability to comply with medication use, study visits, and study procedures
- Written informed consent obtained from subject or study subject's legal representative
Exclusion Criteria:
- Presence of severe CF-related liver disease, including SGOT or SGPT>3 times the normal limits, history of biliary cirrhosis, or portal hypertension
- Severe pulmonary disease, as defined by FEV1 <>
- Elevated serum creatinine or BUN
- Pregnancy
- PT >1.5 time normal
- Diabetes mellitus
- Daily use of NSAIDs or other anticoagulants
- History of fish allergy
- Use of ticlopidine, clopidogrel, dipyridamole
- Use of glucocorticoids
- History of lung transplant or currently on lung transplantation list
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
Contacts and Locations| Contact: Kelly F King, MD | 615 322 7449 | kelly.king@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Kelly F King, MD | Vanderbilt University |
More Information No publications provided
| Responsible Party: | Vanderbilt University Medical Center ( Kelly Fair King, MD ) |
| Study ID Numbers: | 081363 |
| Study First Received: | June 17, 2009 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00924547 History of Changes |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
| Cystic Fibrosis Docosahexanoic Acid DHA isoprostanes fatty acid |
Study placed in the following topic categories:
| Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis | Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |
Additional relevant MeSH terms:
| Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Lung Diseases | Infant, Newborn, Diseases Pancreatic Diseases Cystic Fibrosis Fibrosis |
ClinicalTrials.gov processed this record on June 19, 2009
http://www.clinicaltrials.gov/ct2/show/NCT00924547?term=cystic+fibrosis&recr=Open
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