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

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ClinicalTrials.gov Identifier: NCT01087437
Recruitment Status : Unknown
Verified March 2014 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : March 16, 2010
Last Update Posted : April 1, 2014
Sponsor:
Collaborator:
Amorfical
Information provided by:
Hadassah Medical Organization

Study Description
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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 .


Condition or disease Intervention/treatment Phase
Skeletal Deformities Leg Length Discrepancy Dietary Supplement: gastrolith calcium Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Study Start Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arms and Interventions
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Arm Intervention/treatment
Experimental: gastrolith calcium treatment Dietary Supplement: gastrolith calcium


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087437


Contacts
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Contact: Ron Lamdan, M.D 972-2-6776342 ronl@hadassah.org.il

Locations
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Israel
Hadassah Medical Organizaton Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Amorfical
More Information
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Responsible Party: Ron Lamdan, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01087437    
Other Study ID Numbers: LAM002-HMO-CTIL
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: April 1, 2014
Last Verified: March 2014
Keywords provided by Hadassah Medical Organization:
Distraction osteogenesis
Additional relevant MeSH terms:
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Leg Length Inequality
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
 Pathological Conditions, Anatomical
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs