Vitamin C for Low Stomach Acid

Overseen By Alka Kadariya

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Indiana University

Must not be taking: Antacids, Antisecretory, Proton-pump, H2 blockers

Disqualifiers: Gastrointestinal disease, Abdominal surgeries, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

11 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

Yes, you will need to stop taking any prescription, over-the-counter, or herbal medications that might affect the study results.

What data supports the effectiveness of the treatment Vitamin C for low stomach acid?

Research suggests that vitamin C levels are lower in people with low stomach acid, and increasing vitamin C intake may help improve these levels. Additionally, high doses of vitamin C have been shown to eradicate Helicobacter pylori infection in some patients, which is associated with low stomach acid. ^{1 2 3 4 5}

Is Vitamin C generally safe for humans?

Vitamin C, also known as ascorbic acid, is generally recognized as safe by the U.S. Food and Drug Administration and is widely used in foods and supplements. A long-term study in rats and mice showed that high doses of Vitamin C did not cause cancer, indicating its safety in these animals. ^{3 4 6 7 8}

How does the drug Vitamin C differ from other treatments for low stomach acid?

Vitamin C (ascorbic acid) is unique because it may help increase gastric vitamin C levels, which are often low in people with low stomach acid, potentially protecting against gastric cancer and improving the effectiveness of treatments for Helicobacter pylori infections. ^{3 4 9 10 11}

Eligibility Criteria

This trial is for healthy young men aged 18-30 with no history of gastrointestinal issues. Participants must not have used antibiotics in the last 3 months, any medications that could affect the study, or be current smokers. Pregnant individuals and those with a significant medical history related to abdominal conditions or surgeries are excluded.

Inclusion Criteria

Only young, healthy men between 18 and 30 years old with no past stomach or intestinal issues.

Exclusion Criteria

Ingestion of any prescription, over-the-counter, or herbal medications which may affect study interpretation

You are currently smoking cigarettes.

History of gastric bypass or other abdominal surgeries excluding cholecystectomy or appendectomy > 6 months prior to study initiation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 1000 mg of ascorbic acid to evaluate changes in gastric pH

1 day

1 visit (in-person)

Monitoring

Gastric pH measurements are continuously monitored using a catheter-based pH monitoring system

5 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Vitamin C

Trial Overview The study tests if ascorbic acid (vitamin C) tablets can temporarily lower stomach acidity in people whose low gastric pH has been caused by taking omeprazole, a common medication for acid-related issues.

Participant Groups

Group I: Experimental: omeprazole and ascorbic acid Experimental Treatment 2 Interventions

Vitamin C is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin C for:

• Scurvy
• Dietary supplement

Approved in European Union as Vitamin C for:

• Scurvy
• Dietary supplement

Approved in Canada as Vitamin C for:

• Scurvy
• Dietary supplement

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Hala Fadda

Collaborator

Trials

1

Recruited

10+

Butler University

Collaborator

Trials

1

Recruited

10+

References

1. England pubmed.ncbi.nlm.nih.gov

Vitamin C in the human stomach: relation to gastric pH, gastroduodenal disease, and possible sources. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effects of high dose vitamin C treatment on Helicobacter pylori infection and total vitamin C concentration in gastric juice. [2019]

3. Japan pubmed.ncbi.nlm.nih.gov

A change in gastric mucosal ascorbic acid status with the formation, progression, and recovery of compound 48/80-induced acute gastric mucosal lesions in rats. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Ascorbic acid in the human stomach. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Vitamin C concentration in gastric juice before and after anti-Helicobacter pylori treatment. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

[Influence of gastric juice pH on the metabolism of vitamin C in gastric mucosa and juice]. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A critical role of gastric mucosal ascorbic acid in the progression of acute gastric mucosal lesions induced by compound 48/80 in rats. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

NTP Carcinogenesis Bioassay of L-Ascorbic Acid (Vitamin C) (CAS No. 50-81-7) in F344/N Rats and B6C3F1 Mice (Feed Study). [2019]

9. Belgium pubmed.ncbi.nlm.nih.gov

Ascorbic acid metabolism and cancer in the human stomach. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

Vitamin C, gastritis, and gastric disease: a historical review and update. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Vitamin C and Helicobacter pylori Infection: Current Knowledge and Future Prospects. [2020]