Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

NCT ID: NCT04199624

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-06-07

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Experimental: omeprazole and ascorbic acid

Group Type: EXPERIMENTAL

Omeprazole 20mg

Intervention Type: DRUG

Omeprazole twice daily x 5 days

Vitamin C

Intervention Type: DIETARY_SUPPLEMENT

Ascorbic acid x 1 on day 5

Interventions

Omeprazole 20mg

Omeprazole twice daily x 5 days

Intervention Type: DRUG

Vitamin C

Ascorbic acid x 1 on day 5

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy, young males age 18-30 years with no prior history of gastrointestinal disease or symptoms.

Exclusion Criteria

• Hypochlorhydria (baseline use antacids, antisecretory medications, or surface agents including proton-pump inhibitors, H2 blockers, or sucralfate).
• Current or previous history of gastrointestinal disease including gastroesophageal reflux disease, Barrett's esophagus, peptic ulcer disease, dyspepsia, gastroparesis, bacterial overgrowth, microscopic colitis, gastric intestinal metaplasia or metaplastic atrophic gastritis, gastric neuroendocrine tumors, helicobacter pylori infection, inflammatory bowel disease (Crohn's disease or ulcerative colitis), celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease).
• History of gastric bypass or other abdominal surgeries excluding cholecystectomy or appendectomy > 6 months prior to study initiation.
• Radiation therapy to the abdomen.
• Pregnant females.
• Ingestion of any prescription, over-the-counter, or herbal medications which may affect study interpretation.
• Currently a smoker
• Antibiotic use within the last 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hala Fadda

UNKNOWN

Sponsor Role: collaborator

Butler University

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

John M. Wo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

2006413011

Identifier Type: -

Identifier Source: org_study_id