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

Phase 1

• Conditions: Skeletal Deformities; Leg Length Discrepancy
• Interventions: Dietary Supplement: gastrolith calcium

• Registration Number: NCT01087437
• Lead Sponsor: Hadassah Medical Organization

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 available

Study Timeline

• Study First Submitted: 2010-03-14
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Study Start: 2011-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-30
• Last Update Posted: 2014-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gastrolith calcium treatment	gastrolith calcium	-

Trial Locations

Locations (1)

Hadassah Medical Organizaton; 🇮🇱 Jerusalem, Israel