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Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Hadassah Medical Organization
Sponsor:
Collaborator:
Amorfical
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01087437
First received: March 14, 2010
Last updated: March 30, 2014
Last verified: March 2014

March 14, 2010
March 30, 2014
January 2011
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Complete list of historical versions of study NCT01087437 on ClinicalTrials.gov Archive Site
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Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis
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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 .

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Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
  • Skeletal Deformities
  • Leg Length Discrepancy
Dietary Supplement: gastrolith calcium
Experimental: gastrolith calcium treatment
Intervention: Dietary Supplement: gastrolith calcium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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Inclusion Criteria:

  1. Males and females
  2. Ages 4-30 years old.

Exclusion Criteria:

  1. Product Allergy
  2. Refusal to participate the study.
  3. Metabolic Disorders
Both
4 Years to 30 Years
No
Contact: Ron Lamdan, M.D 972-2-6776342 ronl@hadassah.org.il
Israel
 
NCT01087437
LAM002-HMO-CTIL
Yes
Ron Lamdan, Hadassah Medical Organization
Hadassah Medical Organization
Amorfical
Not Provided
Hadassah Medical Organization
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP