Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01783613
• Date of registration: 31/01/2013
• Prospective Registration: No
• Primary sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Public title: Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis
• Scientific title: Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis
• Date of first enrolment: October 2011
• Target sample size: 96
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01783613
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed of cystic fibrosis over than 2 months age

- Tolerance clinical supplementation with DHA

- Clinical situation stable

Exclusion Criteria:

- Changes in the routine treatment in the 2 weeks prior to baseline

- Admission to hospital or administration of oral or intravenous antibiotics within 2
weeks before inclusion



Age minimum: 2 Months
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months

Dietary Supplement: Placebo: 50 mg/kg/day during 12 months

Primary Outcome(s)

To study whether long-term administration of DHA (12 months), at doses of 50 mg/ kg/day in patients over 2 months age diagnosed of CF decreases inflammation compared with placebo [Time Frame: 12 months]

Secondary ID(s)

Docosahexaenoic acid

Source(s) of Monetary Support

Please refer to primary and secondary sponsors