Clinical Trials Logo
  1. Home
  2. Postmenopause
  3. NCT01338142

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 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.

Clinical Trial 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: ;

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

Clinical Trial Details
NCT number NCT01338142
Study type Interventional
Source Tel-Aviv Sourasky Medical Center
Contact Nachum Vaisman, Professor
Phone 009-972-3-6974807
Email vaisman@tasmc.health.gov.il
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date May 2011
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT05448079 - The Effect of Sexual Counseling Given According to the PLISSIT Model on FSFI, MAS and SQOL-F of Postmenopausal Women N/A
Completed NCT00745173 - Study Evaluating Premarin and Bazedoxifene Potential Interaction Phase 1
Completed NCT00913926 - Effects of Wellnara on Climacteric Symptoms N/A
Completed NCT00550433 - Study Evaluating Bazedoxifene/CE in Postmenopausal Women Phase 1
Completed NCT00381251 - Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Phase 1
Completed NCT00515593 - PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE) N/A
Completed NCT00484107 - Tolerability & Safety of Premarin Vaginal Cream in Indian Postmenopausal Women Phase 4
Completed NCT00185328 - Efficacy and Tolerability of Angeliq in Thai Women Phase 4
Completed NCT00023543 - Reduction of Triglycerides in Women on Hormone Replacement Therapy Phase 2
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Completed NCT00006407 - Sex Steroid Hormones and Risk of CHD in Women N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Completed NCT00006539 - Thrombotic, Inflammatory & Gene Markers of CVD in Women N/A
Completed NCT00005515 - Mutations, Hormone Therapy (HRT) and Venous Thromboembolism N/A
Completed NCT00001752 - Vascular and Metabolic Effects of Hormone Therapy Combined With L-Arginine in Postmenopausal Women Phase 2
Completed NCT00000481 - Women's Health Trial: Feasibility Study in Minority Populations Phase 3
Completed NCT00000466 - Postmenopausal Estrogen/Progestin Interventions (PEPI) Phase 3
Completed NCT00543634 - Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women Phase 1
Completed NCT06115577 - Endometrial Tissues and Mononuclear Cells Receptivity in Pathogenesis of Endometrial Proliferative Processes
Completed NCT01556737 - Effect of Two Different Isoflavone Supplement Preparations on Gene-expression in Postmenopausal Women N/A