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

NCT01338142 | Unknown Phase 1

• 1 other identifier: TASMC-10-NV-571-CTIL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopause

Keywords

postmenopausal; women; absorption; calcium; amorphous calcium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CCC

PLACEBO COMPARATOR

Crystalline calcium carbonate (CCC)

Other: CCC

ACC

EXPERIMENTAL

Amorphous calcium carbonate (ACC)

Other: ACC

Interventions

CCC OTHER

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

CCC

ACC OTHER

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

ACC

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• BMI 18-29 (inclusive)
• Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects who provide written informed consent to participate in the study.

You may not qualify if:

• 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).
• Women with vitamin D deficiency \< 30 ng/ml
• 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.
• Women who take oral steroids, anticonvulsants, bisphosphonates, estrogen compounds, calcitonin, or teriparatide within the past 6 months.
• Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator (PI).
• Subjects who are non-cooperative or unwilling to sign consent form.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Amorphical Ltd.: collaborator

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Central Study Contacts

Nachum Vaisman, Professor

CONTACT

009-972-3-6974807; vaisman@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 19, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 19, 2011

Record last verified: 2011-03

Locations

IL (1)