Oxidative StressEarly Phase 1MNSRPNCT04781868
Multi-Nutrient Supplement for Radio-Protection
A Early Phase 1 study testing Multi-nutrient supplement in people with Oxidative Stress and DNA Damage, Radiation Induced, run by McMaster University.
Trial summary
Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in… Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, DNA Damage, Radiation Induced, Radiation Exposure
- What is being tested?
- Multi-nutrient supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2025
- Phase
- Early Phase 1
- 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 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 76 years.
- Scheduled for bone scan procedure at the Juravinski Hospital.
Who cannot join
- History of smoking within six months prior to study enrollment.
- Known hypersensitivity reactions to any of the ingredients in the MNSRP.
- Chemotherapy or radiation therapy within six months prior or one month following study enrollment.
- Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.
About this study
Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.
- Being tested
- Multi-nutrient supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-nutrient supplementDrug
Multi-nutrient supplement containing a combination of vitamins, minerals and antioxidants
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Multi-nutrient supplement | Experimental | Not described Receives: Drug: Multi-nutrient supplement |
| Placebo supplement | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gamma-H2Ax foci per PBMC nucleus
Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure
Measured: Three hours following radiation exposure
Secondary outcomes (3)
Amount of amplifiable mtDNA in PBMC's
Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure
Measured: Three hours following radiation exposure
Abundance of mtDNA deletions in PBMC's
Abundance of mtDNA deletions in PBMC's three hours following radiation exposure
Measured: Three hours following radiation exposure
Abundance of phosphorus-ATM in PBMC's
Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure
Measured: Three hours following radiation exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781868
- Sponsor's protocol ID
- 13032
- Acronym
- MNSRP
- Status last verified
- Oct 2023
- First submitted
- 25 Feb 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Nutrient Supplement for Radio-Protection
- ClinicalTrials.gov ID
- NCT04781868
- Acronym / sponsor ID
- MNSRP / 13032
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 4 Mar 2021 (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.
Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-nutrient supplement | Experimental | Drug: Multi-nutrient supplement |
| Placebo supplement | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 76 years.
- Scheduled for bone scan procedure at the Juravinski Hospital.
Key exclusion criteria (4 listed)
- History of smoking within six months prior to study enrollment.
- Known hypersensitivity reactions to any of the ingredients in the MNSRP.
- Chemotherapy or radiation therapy within six months prior or one month following study enrollment.
- Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.
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 |
|---|---|---|
| Multi-nutrient supplementMulti-nutrient supplement containing a combination of vitamins, minerals and antioxidants | Drug | Multi-nutrient supplement |
| PlaceboPlacebo | Drug | Placebo supplement |
Primary outcome
Number of gamma-H2Ax foci per PBMC nucleus
Time frame: Three hours following radiation exposure
Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure
3 secondary outcomes
Amount of amplifiable mtDNA in PBMC's
Time frame: Three hours following radiation exposure
Abundance of mtDNA deletions in PBMC's
Time frame: Three hours following radiation exposure
Abundance of phosphorus-ATM in PBMC's
Time frame: Three hours following radiation exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Oxidative Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Multi-nutrient supplement in people with Oxidative Stress and DNA Damage, Radiation Induced, run by McMaster University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Number of gamma-H2Ax foci per PBMC nucleus (time frame: Three hours following radiation exposure). 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 23 Oct 2023.