Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women

Postmenopause Clinical Trial

Official title:

A Randomised, Double-Blind, Crossover Bioavailability Study Comparing Amorphous Calcium Carbonate (Acc) Versus Crystalline Calcium Carbonate (Ccc) Using Stable Calcium Isotopes In Postmenopausal Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01338142
• Other study ID #: TASMC-10-NV-571-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: April 13, 2011
• Last updated: April 17, 2011
• Start date: May 2011
• Est. completion date: July 2012

Study information

• Verified date: March 2011
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, Professor
• Phone: 009-972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The study objective is, to evaluate the fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs crystalline calcium carbonate (CCC) dietary supplements in postmenopausal women.

Description:

This is a randomized, double-blind, crossover bioavailability study comparing the fractional absorption of calcium from amorphous calcium carbonate (ACC) versus crystalline calcium carbonate (CCC) using stable calcium isotopes in postmenopausal women.

The study is comprised of 15 subjects orally administered immediately after breakfast a 600 mg gelatin capsules containing either 600 mg (2 capsules of 300 mg)of ACC (192 mg elemental calcium) of 480 mg CCC (192 mg elemental calcium), labeled with 15 mg of 44Ca (2 capsules of 300 mg).

Five minutes following the oral administration, each subject will be infused intravenously with 1.5 mg of CaCl2 labeled with 42Ca over 10 min. Over the following 24 h subjects will consume meals that will be selected by the Unit of Clinical Nutrition at Sourasky Medical Center nutritionist on the basis of their food diary and ALL urine excreted during this time should be collected in a designated urine container and returned to the Unit of Clinical Nutrition at Sourasky Medical Center for evaluation. The same protocol as in day 0 with a crossover oral treatment will be performed after 21 day washout period.

Dosing day will be designated "Day 0". Eligible subjects are randomly assigned to one of the study treatments according to the following regimens:

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

INCLUSION CRITERIA

• Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

1. BMI 18-29 (inclusive)

2. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.

3. Subjects who provide written informed consent to participate in the study.

EXCLUSION CRITERIA

1. Women who, on the basis of a food frequency questionnaire, have an estimated daily calcium intake >1100 mg through combined diet (both supplements and food).

2. Women with vitamin D deficiency < 30 ng/ml

3. Women with hypercalcemia, nephrolithiasis, inflammatory bowel disease, malabsorption, chronic diarrhea, use of antibiotics within the past month, Woman suffering from digestive, hepatic, renal, or inflammatory diseases.

4. Women who take oral steroids, anticonvulsants, bisphosphonates, estrogen compounds, calcitonin, or teriparatide within the past 6 months.

5. Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator (PI).

6. Subjects who are non-cooperative or unwilling to sign consent form.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Other:
• CCC
600 mg (2 capsules of 300 mg) for oral use of 480 mg CCC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca and 120 mg of inactive filler, sucrose. 1.5 mg of 42Ca labeled CaCl2 through IV injection
• ACC
600 mg (2 capsules of 300 mg) for oral use containing 600 mg ACC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca 1.5 mg of 42Ca labeled CaCl2 through IV injection

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Amorphical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in fractional absorption of calcium from amorphous calcium carbonate (ACC) Vs. crystalline calcium carbonate (CCC).	Fractional absorption will be evaluated by measuring 42Ca and 44Ca levels in the urine over 24 hours (the ratio)	1 year