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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of vitamin C to temporarily lower stomach acid levels in individuals with low acid due to omeprazole, a common heartburn medication. Participants will take vitamin C tablets, and researchers will measure changes in their stomach acid levels. The trial seeks healthy young men without a history of stomach issues and not currently on medications affecting stomach acid. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that vitamin C, also known as ascorbic acid, can safely lower stomach acid levels. One study found that taking 1000 mg of vitamin C tablets significantly reduced stomach acid in individuals using proton pump inhibitors (PPIs), which are medicines that decrease stomach acid.

Vitamin C is usually safe, but excessive intake can lead to side effects. Some individuals might experience diarrhea, stomach pain, heartburn, or headaches with high doses. While these effects are not harmful, they can be uncomfortable. Therefore, it is important to follow the recommended dose to avoid these issues, as vitamin C is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Vitamin C for low stomach acid because it offers a natural alternative to traditional treatments like antacids and proton pump inhibitors (PPIs). Unlike standard treatments that work by neutralizing stomach acid or inhibiting its production, Vitamin C may help enhance the stomach's acid production naturally. This is significant because proper stomach acid levels are crucial for digestion and nutrient absorption. Additionally, Vitamin C's antioxidant properties might offer extra health benefits, potentially improving overall gastrointestinal health.

What evidence suggests that vitamin C might be an effective treatment for low stomach acid?

Research has shown that vitamin C, or ascorbic acid, can temporarily reduce stomach acidity in people taking medications like omeprazole. One study found that taking 1000 mg of vitamin C tablets significantly increased stomach acidity in individuals with low stomach acid due to these medications. This trial will explore the effects of combining omeprazole with vitamin C to determine if it helps balance stomach acid levels when they are too low. People with low stomach acid often have lower vitamin C levels, so taking vitamin C could help improve these levels. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022354925002667

Vitamin C reduces gastric pH in pharmacologically induced ... This pilot study demonstrates that 1000 mg of AA tablets can significantly reduce gastric pH in individuals receiving treatment with PPIs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5746510/

Alleviation of ascorbic acid-induced gastric high ... Although calcium ascorbate showed equivalent antioxidant activity to ascorbic acid, it could attenuate the gastric high acidity caused by ascorbic acid.

3. withpower.com withpower.com/trial/phase-1-achlorhydria-9-2021-a857c

Vitamin C for Low Stomach Acid · Info for Participants 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, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04199624

Assessment of Gastric pH Changes Induced by Ascorbic ... This study evaluates the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhydria. All ...

5. mdpi.com mdpi.com/2072-6643/17/2/279

Enhanced Vitamin C Delivery: A Systematic Literature ... At 24 h, calcium ascorbate with metabolites significantly increased leukocyte vitamin C concentrations compared to ascorbic acid alone (1.3 to 1.7 times higher, ...

6. fishersci.com fishersci.com/store/msds?partNumber=BP351500&productDescription=L-ASCORBIC+ACID+500G&vendorId=VN00033897&countryCode=US&language=en

SAFETY DATA SHEET Physical State. Solid. Appearance. Light yellow. Odor. Odorless. Odor Threshold. No information available. pH. 2.1 - 2.6 (5 %).

7. sigmaaldrich.com sigmaaldrich.com/US/en/sds/sial/a92902?userType=anonymous&srsltid=AfmBOopI3j54qg_0GfrmDNqKrv_lIq8oGmZFGrP7VJGrJCF3QsHCpHDr

SAFETY DATA SHEET RTECS: CI7650000. Chronic ingestion of large doses may cause gastrointestinal disturbances including nausea and diarrhea, urinary effects ...

8. health.state.mn.us health.state.mn.us/communities/environment/envlab/sdsinfo/AscorbicACID40mLVOC.pdf

Ascorbic acid Material Safety Data Sheet Most important symptoms/effects, acute and delayed. Symptoms: May cause irritation to skin, eyes, and respiratory tract. Indication of immediate ...