Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis
1 other identifier
interventional
N/A
1 country
1
Brief Summary
BACKGROUND: Distraction osteogenesis, the gradual lengthening of bones, is performed in order to equalize leg length discrepancy and correct skeletal deformities or to achieve greater height in short stature people. The femur and tibia are the bones most frequently lengthened. The surgery is currently performed at Hadassah Medical Center routinely by the pediatric orthopedic team utilizing a variety of external fixation devices. The procedure involves application of an external fixation device to the bone, creation of an osteotomy and gradual, controlled distraction of the bone fragments On the last week of the distraction phase and every month thereafter, patients will be provided with a monthly supply of gastrolith calcium in a sealed container (65 capsules of 500 mg each, provided by Amorphical). Starting on the first day of the last week of the distraction phase, during the entire consolidation phase until the external fixator is removed; adults will orally consume two (2) 500 mg capsules a day (total of 1 gr of gastrolith calcium). Children will be given 25 mg calcium per kg body weight up to the daily adult dose of 1000mg .
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedApril 1, 2014
March 1, 2014
March 14, 2010
March 30, 2014
Conditions
Keywords
Study Arms (1)
gastrolith calcium treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Males and females
- Ages 4-30 years old.
You may not qualify if:
- Product Allergy
- Refusal to participate the study.
- Metabolic Disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hadassah Medical Organizationlead
- Amorficalcollaborator
Study Sites (1)
Hadassah Medical Organizaton
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 14, 2010
First Posted
March 16, 2010
Study Start
January 1, 2011
Last Updated
April 1, 2014
Record last verified: 2014-03