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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01087437
First Posted: March 16, 2010
Last Update Posted: April 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Amorfical
Information provided by:
Hadassah Medical Organization
  Purpose

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 Intervention Phase
Skeletal Deformities Leg Length Discrepancy Dietary Supplement: gastrolith calcium Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Study Start Date: January 2011
Arms Assigned Interventions
Experimental: gastrolith calcium treatment Dietary Supplement: gastrolith calcium

  Eligibility

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

Locations
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

Responsible Party: Ron Lamdan, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01087437     History of Changes
Other Study ID Numbers: LAM002-HMO-CTIL
First Submitted: March 14, 2010
First Posted: March 16, 2010
Last Update Posted: April 1, 2014
Last Verified: March 2014

Keywords provided by Hadassah Medical Organization:
Distraction osteogenesis

Additional relevant MeSH terms:
Leg Length Inequality
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical