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

Primary Purpose

Skeletal Deformities, Leg Length Discrepancy

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
gastrolith calcium
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skeletal Deformities focused on measuring Distraction osteogenesis

Eligibility Criteria

4 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hadassah Medical OrganizatonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gastrolith calcium treatment

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 14, 2010
Last Updated
March 30, 2014
Sponsor
Hadassah Medical Organization
Collaborators
Amorfical
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1. Study Identification

Unique Protocol Identification Number
NCT01087437
Brief Title
Testing the Effect of Crustacean's Gastrolith Nutraceutical on Mineralization Rate During Distraction Osteogenesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization
Collaborators
Amorfical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal Deformities, Leg Length Discrepancy
Keywords
Distraction osteogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Arm Title
gastrolith calcium treatment
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
gastrolith calcium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females Ages 4-30 years old. Exclusion Criteria: Product Allergy Refusal to participate the study. Metabolic Disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Lamdan, M.D
Phone
972-2-6776342
Email
ronl@hadassah.org.il
Facility Information:
Facility Name
Hadassah Medical Organizaton
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il

12. IPD Sharing Statement

Learn more about this trial

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

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