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OpenTrials
Completed

NCT Number: NCT03462056

Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis

Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes. This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.

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Key information

Conditions

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

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cystic Fibrosis diagnosed by sweat test or genetic testing.
  • Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy
  • BMI or weight for age of less than the 50th percentile

Exclusion criteria

  • Cystic fibrosis related diabetes mellitus
  • Cystic fibrosis related liver disease.
  • Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.
  • Patients who are status-post lung or liver transplantation
  • Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.

Treatment and study plan

Cystic Fibrosis Ready to Use Supplemental Food

Dietary Supplement

Specially formulated for use by children with Cystic Fibrosis

Primary outcomes

  1. BMI Z-score

    Time frame: 3 months

    Change in BMI Z-score

Secondary outcomes

  1. Weight Z-score

    Time frame: 3 months

    Change in Weight Z-score

  2. Body Composition

    Time frame: 3 months

    Percent body fat mass and lean mass as measured by air displacement plethysmography

  3. Body Composition

    Time frame: 3 months

    Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)

  4. Pulmonary Function

    Time frame: 3 months

    Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)

  5. Compliance of taking supplemental food

    Time frame: 3 months

    Percent consumed as compared to amount recommended.

  6. Quality of Life

    Time frame: 3 months

    Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 12, 2018
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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