Effect of Proton Pump Inhibitor on Bioavailability of Effervescent Calcium Magnesium Citrate

Study ID
STU 082012-030

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Ashlei Johnson-Wilder
214-648-0394
ashlei.johnson@utsouthwestern.edu

Principal Investigator
Khashayar Sakhaee

Summary

Study design: The patients will undergo a single dose bioavailability study in a randomized four-phase crossover design, comprised of effCaMgCit plus oMP, effCaMgCit plus PLC, Calcium Carbonate plus oMP and Calcium Carbonate plus PLC. The order of the four phases will be randomized.

Procedures and evaluations during the Research
They will undergo a 7-day assessment for each study medication in a random order:
Days 1-6 of each phase:
* They will be instructed to eat a diet restricted in calcium (400 milligrams per day) and sodium (100 milliequivalents per day) at home.
* They will keep a food diary during this period.
* They will take either omeprazole 20 milligrams or placebo twice a day on an empty stomach before breakfast and after dinner.
* on day 6, They will avoid solid food from 6:00pm and will drink 300 milliliters of distilled water at 8:00pm and at 11:00pm.

Day 7 of each phase:
* at 6:00am, they will take the last dose of omeprazole 20mg or placebo, empty your bladder and discard the urine, and will drink 300 ml of distilled water.
* at 8:00am, they will collect a 2-hour pre-load urine sample and have a fasting blood sample taken.
* They will then drink the test medication in 400 ml of deionized-filtered water with a low calcium breakfast that will be provided.
* They will have blood samples taken hourly thereafter from 8:00am x 2:00pm; the amount of blood drawn will be about 9 teaspoons.
* They will drink 250 ml of distilled water at 9:00am, 10:00am, 11:00am, 12:00pm, and 1:00pm.
* They will collect hourly urine samples from 8:00am x 2:00pm.

There will be at least two weeks of withdrawal period between phases, when the patients will not take any omeprazole or placebo.

Participant Eligibility

Subjects will be adults (age >= 21 years) of either gender or any ethnicity.