NCT04199624

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Male
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhydria. All participants will receive ascorbic acid tablets to measure the change in gastric pH.

Detailed description

Elevation of gastric pH in patients with hypochlorhydria can reduce the solubility of weakly basic drugs. This may lead to poor and unpredictable systemic exposure for poorly soluble drugs. For example, extent of absorption of the kinase inhibitors, dasatinib (Sprycel) and erlotinib (Tarceva), is reduced by up to 61% and 46% respectively in patients on acid-reducing agents (ARAs). This pilot study is to evaluate the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhdyria. Using pH/impedance testing, we are seeking to determine the magnitude and duration of pH change upon administration of 1000 mg of ascorbic acid in healthy subjects with proton-pump inhibitor induced hypochlorhydria. The results from this study will be used to evaluate the use of ascorbic acid as a drug-drug interaction mitigation strategy.

Conditions

• Hypochlorhydria

Interventions

Type	Name	Description
DRUG	Omeprazole 20mg	Omeprazole twice daily x 5 days
DIETARY_SUPPLEMENT	Vitamin C	Ascorbic acid x 1 on day 5

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2019-12-16
• Last updated: 2025-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study