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
  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
Endpoint Classification: Safety/Efficacy Study
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

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ron Lamdan, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01087437     History of Changes
Other Study ID Numbers: LAM002-HMO-CTIL
Study First Received: March 14, 2010
Last Updated: March 30, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014