NCT06971315

Brief Summary

Non-opioid treatments are increasingly sought after for managing acute pain. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., Advil, Motrin, Naproxen) combined with acetaminophen (e.g., Tylenol) have become an alternative for relieving acute pain. However, many patients cannot tolerate or have contraindications to NSAIDs and acetaminophen. There is therefore an urgent need for studies evaluating the analgesic effects of vitamin C in the context of acute pain. Our study is conducted with healthy volunteer participants receiving either vitamin C or a placebo to assess the analgesic effect of vitamin C by comparing pain detection and tolerance thresholds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 18, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

19 days

First QC Date

May 6, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

Vitamin CAlgometerPain detectionPain threshold

Outcome Measures

Primary Outcomes (1)

  • Pressure pain detection threshold (PPDT)

    Pressure pain detection threshold (PPDT) measured with an algometer one to three hours after the last dose of the study drug (24 hours after the first dose of vitamin C or placebo).

    24 hours

Secondary Outcomes (3)

  • Pressure pain detection threshold one to three hours after the first study drug dose

    1 hours

  • Pressure pain tolerance threshold (PPTT) one to three hours after the last dose of the study drug

    24 hours

  • Pressure pain tolerance threshold (PPTT) one to three hours after the first dose of the study drug

    1 hour

Study Arms (2)

Vitamin C

EXPERIMENTAL

Three doses of 900 mg of vitamin C taken orally every 12 hours for 24 hours (baseline, 12 hours and 24 hours)

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Three doses of 900 mg of placebo taken orally every 12 hours for 24 hours (baseline, 12 hours and 24 hours)

Other: Placebo

Interventions

PlaceboOTHER

Three doses of 900 mg placebo taken orally (baseline, 12 hours and 24 hours)

Placebo
Vitamin CDIETARY_SUPPLEMENT

Three doses of 900 mg vitamin C taken orally (baseline, 12 hours and 24 hours)

Vitamin C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 to 65 years old;
  • No acute or chronic pain;
  • No pain medication;
  • French or English-speaking

You may not qualify if:

  • Currently using vitamin C supplements;
  • Pain in the last week or active cancer;
  • Unavailable for follow-up;
  • Allergy to milk (lactose in the placebo), or vitamin C,
  • Treated with cyclosporine or warfarin (interaction with vitamin C);
  • Pre-existing oxalate nephropathy, liver cirrhosis or hemochromatosis;
  • Evidence of joint or overlying skin infection in the areas of testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double-blind randomized placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Emergency Medicine, Professor, Clinician Researcher

Study Record Dates

First Submitted

May 6, 2025

First Posted

May 14, 2025

Study Start

July 18, 2025

Primary Completion

August 6, 2025

Study Completion

December 19, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations