Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

NCT06102577 | Completed

• 1 other identifier: OMT and Vit.C
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this triple-blind randomized clinical trial is to learn about systemic adverse effects in first visit patients who attend an osteopathic medicine center in Barcelona. The main question it aims to answer are: • Check if there is a relationship between taking vitamin C and the reduction in the appearance of systemic adverse effects after osteopathic treatment (24-72 hours) First-visit patients, at the end of treatment, are asked to enter the study. If they accept, they are administered 1g. of vitamin C, or 1g. placebo or nothing. If there is a comparison group: Researchers will compare placebo group, control group and intervention group to see if there is a relationship between taking vitamin C and the appearance of systemic adverse effects\].

Conditions

Adverse Effects; Ascorbic Acid; Oxidative Stress

Keywords

Osteopathic Medicine; Manipulation, Osteopathic; Adverse effects; Vitamine C; Ascorbic Acid; Oxidative Stress

Outcome Measures

Primary Outcomes (1)

• Probability of suffering systemic adverse effects

  Odds Ratio

  3 days

Study Arms (3)

1gr. Vitamine C

EXPERIMENTAL

Take 1g. of vitamin C at the end of an osteopathic manual treatment

Dietary Supplement: 1gr. Vitamine C

1gr.Placebo

PLACEBO COMPARATOR

Take 1g. of placebo at the end of an osteopathic manual treatment

Other: 1gr Placebo

control group

SHAM COMPARATOR

control

Other: control group

Interventions

1gr. Vitamine C DIETARY_SUPPLEMENT

Take 1g. of vitamin C at the end of an osteopathic manual treatment

1gr. Vitamine C

1gr Placebo OTHER

ake 1g. of placebo at the end of an osteopathic manual treatment

1gr.Placebo

control group OTHER

control

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first-visit patients
• of legal age,
• without food allergies or intelorenacies
• the ability to receive and send messages via WhatsApp.

Sponsors & Collaborators

• Centre Medicina Esportiva i Osteopatia, Spain: lead

Study Sites (1)

Medicina Esportiva i Osteopatia

Mollet del Vallès, Barcelona, 08100, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rafael Merino Solis, MD

  CMosteoesport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient is randomized at the end of the treatment and the person in charge of collecting the data does not know which group each patient belongs to.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rafael Merino Solis MD.

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 26, 2023
• Study Start: November 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)