Trial Outcomes & Findings for The Effect of Protein on Calcium Absorption and Gastric Acid Production (NCT NCT00719160)

Results Overview

This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Day 5 of a high protein diet

Results posted on

2020-03-06

Participant Flow

12 healthy women and men enrolled

Participants received either Esomeprazole or placebo first and then crossed over to receive the other intervention with a minimum 2 week washout in-between.

Participant milestones

Participant milestones
Measure	Intervention Esomeprazole First/Placebo Second In this group this group received the intervention first and then the placebo	Intervention Placebo First/Esomeprazole Second In this group this group received the placebo first and then the intervention
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Protein on Calcium Absorption and Gastric Acid Production

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=12 Participants Includes groups randomized to receive 20 mg twice daily of either placebo or esomeprazole first
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	30.9 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5 of a high protein diet

This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.

Outcome measures

Outcome measures
Measure	Esomeprazole n=12 Participants Esomeprazoled administered twice daily in either first or second intervention period	Placebo n=12 Participants Placebo administered twice daily in either first or second intervention
Percent Change in Intestinal Calcium Absorption	34.2 percentage of calcium absorption Standard Error 2.4	31.5 percentage of calcium absorption Standard Error 2.1

SECONDARY outcome

Timeframe: Day 5 of a high protein diet

The American Heritage Dictionary defines pH as "a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14." The normal pH range for stomach acid is between 1.5 and 3.5.

Outcome measures

Outcome measures
Measure	Esomeprazole n=12 Participants Esomeprazoled administered twice daily in either first or second intervention period	Placebo n=12 Participants Placebo administered twice daily in either first or second intervention
Gastric pH	5.38 units on a scale of pH Standard Error 0.13	2.70 units on a scale of pH Standard Error 0.44

Adverse Events

Entire Study Population

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karl L. Insogna, M.D.

Yale University

Phone: 203-737-2871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place