Clinical Trial: Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health

Brief Summary: This is a randomized clinical trial comparing Omegaven® treatment with standard of care (soybean-based lipid formulation, Intralipid®) on bone health outcomes in infants with esophageal atresia (EA) undergoing surgical repair at Boston Children's Hospital.

Detailed Summary:

Medical treatments and disease pathophysiology can result in prolonged immobilization that places hospitalized infants and children at risk for serious musculoskeletal complications including bone loss, fragility fractures, and muscle atrophy. Patients at the highest risk for inpatient fracture include premature infants, children with cerebral palsy, spinal cord injury, neuromuscular disorders (e.g., Duchenne Muscular Dystrophy or Spinal Muscular Atrophy), lengthy post-operative immobilization such as esophageal atresia (EA), and prolonged use of parenteral nutrition (PN). These fractures can result in significant discomfort, increase medical costs, may require surgical intervention, and may result in long term deleterious effects on musculoskeletal health.

Omega-3 polyunsaturated fatty acids (O3PuFA) are important bio-mediators modulating bone formation and remodeling. We demonstrated that O3PuFA provide protection of bone microstructure by increasing the number of trabecular elements and subsequently strengthening the trabecular network in young mice. Human studies suggest an association between O3PuFA intake and increased bone mineral density (BMD) in adults, and we also demonstrated decreased fracture risk in infants. O3PuFA may reduce bone resorption by modulating inflammatory cytokines and inhibiting osteoclast differentiation and activity, and may also increase bone formation by increasing osteoblast differentiation and activity, which may provide the explanation for the observed skeletal benefits.

In this study, we propose the use of intravenous O3PuFA (Omegaven® , Fresenius Kabi, Bad Hamburg Germany) administration for the prevention of musculoskeletal complications due to immobilization in infants. Boston Children's Hospital (BCH) has more than 15 years' experience with this O3PuFA product, having treated mo
Sponsor: Boston Children’s Hospital

Current Primary Outcome: Change in total volumetric bone mineral density of the distal femur [ Time Frame: Baseline and 28 days ]

Computed tomography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cortical and trabecular volumetric bone mineral density of the distal femur [ Time Frame: Baseline and 28 days ]
    Computed tomography
  • Bone geometry and bone strength estimates of the distal femur [ Time Frame: Baseline and 28 days ]
    Computed tomography
  • Bone turnover markers [ Time Frame: Baseline, 14 days, and 28 days ]
    Blood and urine testing
  • Incidence of fracture [ Time Frame: 28 days ]
    Incidence of fracture
  • Incidence of adverse events [ Time Frame: Daily for 28 days ]
    Incidence of adverse events


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: April 7, 2017
Date Started: March 2018
Date Completion: July 2021
Last Updated: April 20, 2017
Last Verified: April 2017