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Bone Density in Children With IBD Treated With Amorphous Calcium or Commercial Crystalline Calcium

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.
 
ClinicalTrials.gov Identifier: NCT02470663
Recruitment Status : Withdrawn (company and Sheba did not reach an agreement)
First Posted : June 12, 2015
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Batia Weiss, Sheba Medical Center

Brief Summary:
Patients diagnosed with, or in risk of osteoporosis regularly take calcium dietary supplements, although their contribution to BMD maintenance, prevention of bone loss or reduction of the risk of fracture is questionable. Freshwater crayfish rely on amorphous calcium carbonate (ACC), a thermodynamically instable and very rare biomineralized polymorph of calcium carbonate, as the main mineral in the exoskeleton and in their temporary storage organ, the gastrolith. The study hypothesis is that amorphous calcium carbonate (ACC) will have an advantage over calcium carbonate in improving BMD of pediatric IBD patients with reduced BMD. The investigators will include children 10-18 years old with IBD and reduced bone density to recieve regular calcium or amorphic calcium for 12 months with follow up of bone density and confounders as disease activity and medications.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Dietary Supplement: DENSITYTM caplets (marketed as Amorphical) Dietary Supplement: Calcium carbonate 600 mg once daily Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bone Density in Children With IBD Treated With Amorphous Calcium or Commercial Crystalline Calcium: A Prospective Randomized Multicenter Trial
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Children recieving DENSITYTM caplets (marketed as Amorphical) 200 mg BID for 12 months
Dietary Supplement: DENSITYTM caplets (marketed as Amorphical)
supplementation

Active Comparator: Control group
Children recieving Calcium carbonate 600 mg once daily for 12 months
Dietary Supplement: Calcium carbonate 600 mg once daily
supplementation




Primary Outcome Measures :
  1. The primary efficacy endpoint is improvement of spine bone density by 0.5 points in Z -score after 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Improvement of spine bone density by at least 0.25 points in Z -score after 12 months [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children 10-18 years old.
  2. Confirmed diagnosis of IBD
  3. Able to swallow pills.
  4. Osteopenia or osteoporosis (spine Z score lower than -1.0) on baseline bone scan.
  5. Informed consent.

Exclusion Criteria:

  1. Inadequate bone marrow, renal or hepatic function.
  2. Significant concurrent disease.
  3. Allergy to calcium or vitamin D preparations.
  4. Pathologic hypercalciuria. 5. Patient non-compliance. 6. Pregnancy

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): NCT02470663


Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Batia Weiss, MD Sheba Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Batia Weiss, Director, Pediatric Gastroenterology and Nutrition Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02470663    
Other Study ID Numbers: 1957-15
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents