A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients

Study ID
STU 112012-064

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Children's Medical Center (Dallas, Plano, Southlake)

Contact
Ashley Keller
214/648-2817
ashley.keller@utsouthwestern.edu

Principal Investigator
Raksha Jain

Summary

This will be a multicenter, randomized, controlled, double-blind, Phase ii clinical trial.
eighty pancreatic insufficient (Pi) subjects with CF, [GreaterThanorequalTo] 10 years of age will be enrolled to
participate in this study.
each subject will come to clinic for up to 5 study visits (see Figure 1). Screening: Visit 1
(Screening, Day -28 up to -60), Visit 2 (Baseline, Day 0), Visit 3 (Week 4, Day 28) and Visit 4
(Week 16, Day 112). Following the screening visit, there will be a four to eight-week open-label
screening/run-in period in which subjects will be instructed to discontinue their current CF
multivitamin and any additional vitamin supplementation and take a control multivitamin
without antioxidant enrichment (containing standard amounts of vitamins a, B, D, e, K).
at Visit 2 (Baseline), subjects will be randomized to receive either aquaDeKs-2 or to
continue on the control multivitamin once daily for an additional 16 weeks. Safety and
tolerability will be monitored. a fasting blood draw for vitamin and nutrient levels and
systemic markers of inflammation and oxidative stress, anthropometric measures, and
pulmonary function will be obtained at Visits 2 (Baseline), 3 and 4. induced sputum and
urine specimens will be collected at Visits 2 and 4 to measure markers of airway
inflammation and oxidative stress. Subjects will be contacted by phone 2 weeks after
Visit 4 to assess safety. if a subject had a clinically significant abnormal lab result or ongoing
treatment-related ae at Visit 4, the subject will be asked to return for a follow-up
visit two weeks after Visit 4 instead of the call.

Subjects will be on study for up to 26 weeks:
Screening/Run-in: 4-8 weeks
Treatment: 16 weeks
Follow-up: 2 weeks

Participant Eligibility

1. Male or female >=10 years of age
2. Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent
with the CF phenotype and 1 or more of the following criteria:

* Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine
iontophoresis test (QPIT)

* 2 well-characterized mutations in the CFTR gene
3. Pancreatic insufficiency documented by having a spot fecal elastase-1 (FE-1) <= 100
[MICRO-SYMBOL]g/g in a stool sample done either historically or at the screening visit
4. Clinically stable with no significant changes in health status within 2 weeks prior to
randomization
5. FEV1 >= 40 and <= 100% of predicted for age based on the Wang (males < 18 years,
females < 16 years) or Hankinson (males>= 18 years, females >= 16 years) standardized
equations at the screening visit
6. Weight >= 30 kg at the screening visit
7. Able to perform repeatable, consistent efforts in pulmonary function testing
8. Able to tolerate sputum induction with 3% hypertonic saline and to expectorate with
induction
9. Written informed consent (and assent when applicable) obtained from subject or
subject[Single Quote]s legal representative
10. Ability to swallow softgel capsules