Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis

NCT01018303 | Completed Phase 1

• 1 other identifier: 07-0355
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and efficacy of the final commercial formulation of an antioxidant enriched multivitamin supplement in softgel capsule form (AquADEKs) in increasing the plasma levels of certain nutrients and antioxidants in individuals with cystic fibrosis. Hypothesis: An oral antioxidant-rich multivitamin supplement (AquADEKs), which uses a Generally Regarded As Safe (GRAS) molecule to form micelle-like vehicles, will safely increase systemic levels of beta-carotene, coenzyme Q10, and gamma-tocopherol, decrease PIVKA-II levels, while maintaining levels of vitamins A and D in the normal range in persons with CF \> 10 years of age.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; vitamins; antioxidants; anthropometric measurements; pulmonary function

Outcome Measures

Primary Outcomes (1)

• Plasma levels of beta-carotene

  12 weeks

Secondary Outcomes (1)

• Plasma levels of coenzyme Q10, retinol (Vitamin A), 25-hydroxy vitamin D, alpha- and gamma-tocopherols (Vitamin E), PIVKA-II

  12 weeks

Study Arms (1)

Antioxidant-enriched multivitamin supplement

EXPERIMENTAL

Dietary Supplement: AquADEK

Interventions

AquADEK DIETARY_SUPPLEMENT

Two AquADEK softgel vitamins on a daily basis x 12 weeks

Antioxidant-enriched multivitamin supplement

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of CF as evidenced by a sweat chloride test \> 60mEq/L or by the presence of two known CF mutations
• Male or female, ages between 10-40 years old
• \> 30 kg body weight
• FEV1 \> 35% predicted for age and height
• Clinically stable with no recent hospitalization within the past 2 weeks

You may not qualify if:

• Significant liver disease as defined by clinical findings of portal hypertension or cirrhosis or AST, ALT, or GGT \>2x upper limits of normal within the previous 6 months
• Poor compliance with medical regimen as assessed by CF clinic care providers
• Oral supplementation with AquADEKs or another source of beta-carotene or CoQ10 in the 2 months prior to the study
• Pregnant or lactating
• Participation in another interventional clinical trial within the previous 2 weeks
• Difficulty swallowing softgels

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cystic Fibrosis Foundation: collaborator
• Yasoo Health: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Children's Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Sagel SD, Sontag MK, Anthony MM, Emmett P, Papas KA. Effect of an antioxidant-rich multivitamin supplement in cystic fibrosis. J Cyst Fibros. 2011 Jan;10(1):31-6. doi: 10.1016/j.jcf.2010.09.005. Epub 2010 Oct 20.

  PMID: 20961818 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Scott D Sagel, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: August 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2009
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

US (1)