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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Amorfical

Information provided by:

Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT01087437

First received: March 14, 2010

Last updated: July 30, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2010
Last Updated Date	July 30, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01087437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis
Official Title ^ICMJE	Not Provided
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 .
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment
Condition ^ICMJE	Skeletal Deformities Leg Length Discrepancy
Intervention ^ICMJE	Dietary Supplement: gastrolith calcium
Study Arm (s)	Experimental: gastrolith calcium treatment Intervention: Dietary Supplement: gastrolith calcium
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females Ages 4-30 years old. Exclusion Criteria: Product Allergy Refusal to participate the study. Metabolic Disorders
Gender	Both
Ages	4 Years to 30 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01087437
Other Study ID Numbers ^ICMJE	LAM002-HMO-CTIL
Has Data Monitoring Committee	Yes
Responsible Party	Ron Lamdan, Hadassah Medical Organization
Study Sponsor ^ICMJE	Hadassah Medical Organization
Collaborators ^ICMJE	Amorfical
Investigators ^ICMJE	Not Provided
Information Provided By	Hadassah Medical Organization
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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