Adverse EffectsNCT06102577
Systemic Adverse Effects After Osteopathic Treatment and Vitamin C
A study testing 1gr. Vitamine C in people with Adverse Effects and Ascorbic Acid, run by Centre Medicina Esportiva i Osteopatia, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Effects, Ascorbic Acid, Oxidative Stress
- What is being tested?
- 1gr. Vitamine C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-visit patients
- of legal age,
- without food allergies or intelorenacies
- the ability to receive and send messages via WhatsApp.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Adverse Effects After Osteopathic Treatment and the Preventive Effect of Vitamin C: Triple-blind Clinical Trial
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].
Read the detailed description
Introduction Systemic adverse effects (SAE) after osteopathic treatment are rarely reported in the scientific literature. There is a consensus in the scientific literature that these adverse effects occur with a certain frequency, without it being clear what the pathophysiology of such effects is. The relationship between free radicals and central sensitization to pain is increasingly evident. Vitamin C is known as a good electron receptor that is used by the body's antioxidant systems to reduce and also has anti-inflammatory properties. The brain has deficiencies in antioxidant systems and vitamin C has a very important role in the control of oxidative stress.
Objective 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).
Design Triple-blind randomized clinical trial, where one group was given 1g of vitamin C, another group was given 1g of placebo and the third group was given nothing. From April 1 to May 30, 2022, patients without food allergies or intolerances were recruited. The patients were randomly assigned to the study groups and neither the patient, nor the therapist, nor the person in charge of collecting the data was aware of which group each patient belonged to. Adverse reactions were classified in relation to pain and fatigue. Data collection was carried out through WhatsApp messages to the patients 72 hours after receiving the treatment.
- Conditions
- Adverse Effects, Ascorbic Acid, Oxidative Stress
- Being tested
- 1gr. Vitamine C, 1gr Placebo, control group
- Keywords
- Osteopathic Medicine, Manipulation, Osteopathic, Adverse effects, Vitamine C, Ascorbic Acid, Oxidative Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1gr. Vitamine CDietary supplement
Take 1g. of vitamin C at the end of an osteopathic manual treatment
1gr PlaceboOther
ake 1g. of placebo at the end of an osteopathic manual treatment
control groupOther
control
| Study group | Role | What they receive |
|---|---|---|
| 1gr. Vitamine C | Experimental | Take 1g. of vitamin C at the end of an osteopathic manual treatment Receives: Dietary Supplement: 1gr. Vitamine C |
| 1gr.Placebo | Placebo comparator | Take 1g. of placebo at the end of an osteopathic manual treatment Receives: Other: 1gr Placebo |
| control group | Sham comparator | control Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of suffering systemic adverse effects
Odds Ratio
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Medicina Esportiva i Osteopatia, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Merino Solis, Centre Medicina Esportiva i Osteopatia, Spain
- Investigators
- Rafael Merino Solis, MD, Principal investigator, CMosteoesport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102577
- Sponsor's protocol ID
- OMT and Vit.C
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Adverse Effects After Osteopathic Treatment and the Preventive Effect of Vitamin C: Triple-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06102577
- Acronym / sponsor ID
- OMT and Vit.C
- Conditions
- Adverse Effects, Ascorbic Acid, Oxidative Stress
- Keywords
- Osteopathic Medicine, Manipulation, Osteopathic, Adverse effects, Vitamine C, Ascorbic Acid, Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Medicina Esportiva i Osteopatia, SpainUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Detailed description
Introduction Systemic adverse effects (SAE) after osteopathic treatment are rarely reported in the scientific literature. There is a consensus in the scientific literature that these adverse effects occur with a certain frequency, without it being clear what the pathophysiology of such effects is. The relationship between free radicals and central sensitization to pain is increasingly evident. Vitamin C is known as a good electron receptor that is used by the body's antioxidant systems to reduce and also has anti-inflammatory properties. The brain has deficiencies in antioxidant systems and vitamin C has a very important role in the control of oxidative stress.
Objective 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).
Design Triple-blind randomized clinical trial, where one group was given 1g of vitamin C, another group was given 1g of placebo and the third group was given nothing. From April 1 to May 30, 2022, patients without food allergies or intolerances were recruited. The patients were randomly assigned to the study groups and neither the patient, nor the therapist, nor the person in charge of collecting the data was aware of which group each patient belonged to. Adverse reactions were classified in relation to pain and fatigue. Data collection was carried out through WhatsApp messages to the patients 72 hours after receiving the treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1gr. Vitamine C | Experimental | Dietary Supplement: 1gr. Vitamine CTake 1g. of vitamin C at the end of an osteopathic manual treatment |
| 1gr.Placebo | Placebo comparator | Other: 1gr PlaceboTake 1g. of placebo at the end of an osteopathic manual treatment |
| control group | Sham comparator | Other: control groupcontrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first-visit patients
- of legal age,
- without food allergies or intelorenacies
- the ability to receive and send messages via WhatsApp.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1gr. Vitamine CTake 1g. of vitamin C at the end of an osteopathic manual treatment | Dietary supplement | 1gr. Vitamine C |
| 1gr Placeboake 1g. of placebo at the end of an osteopathic manual treatment | Other | 1gr.Placebo |
| control groupcontrol | Other | control group |
Primary outcome
Probability of suffering systemic adverse effects
Time frame: 3 days
Odds Ratio
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Merino Solis, MD principal investigator
CMosteoesport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1gr. Vitamine C in people with Adverse Effects and Ascorbic Acid, run by Centre Medicina Esportiva i Osteopatia, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of suffering systemic adverse effects (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.