Drug AbuseNCT05712044
Effect of Folic Acid on the Presentation of Nuclear Abnormalities in People With a History Drug Abuse
A study testing Folic Acid 5 MG in people with Drug Abuse and Genotoxicity, run by Centro Universitario de Tonalá at 1 site in Mexico.
Trial summary
Background: Multiple studies have pointed to the harmful potential of licit and illicit drugs. as agents associated with neoplastic processes and other non-communicable diseases, for which reason It has become a problem of global size. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse, Genotoxicity
- What is being tested?
- Folic Acid 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2023to 1 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Having used legal and illegal drugs.
- Men or women without diseases
Who cannot join
- People who at the moment of the study or 3 months before:
- Have consumed any dietary supplement or vitamin such as folates, B12,
- C, E, A, lutein or melatonin, or some other antioxidant, medications for
- pharmacological treatment of chronic disease and/or periodontal disease
- severe active.
- That they were exposed to fertilizers, radiation, metals heavy or who live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas).
- Individuals who after have been informed of the advantages and risks of participating in the study, decide not to be part of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Folic Acid Supplementation on the Presentation of Nuclear Abnormalities Associated With Cytogenotoxic Damage Induced by Chronic Drug Use.
Background: Multiple studies have pointed to the harmful potential of licit and illicit drugs.
as agents associated with neoplastic processes and other non-communicable diseases, for which reason It has become a problem of global size. Objective: The central objective is to determine the cytogenotoxic damage in the oral mucosa of people with chronic drug use, as well as establishing the therapeutic effect of acid administration folic on said damage. Methodology: Quasi-experimental study, pretest-posttest design with no control group.
Read more
equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents. Resources and infrastructure: The study will be carried out in the pharmacology laboratory of the Center University of Tonalá, who will make their equipment and reagents available. Group experience: The research group has over a decade of experience in the development of projects related to mutagenesis and cyto-genotoxic agents.
Development time: The project will be developed from February 2023 to August of 2023
Read the detailed description
Objectives.
- General Objective. To determine the effect of folic acid supplementation on the presentation of nuclear abnormalities associated with cytogenotoxic damage in healthy subjects and chronic drug users.
- Specific objectives.
- Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group.
- To compare baseline cytogenotoxic damage determinations with subsequent damage determinations, at 15 and 30 days, in chronic drug users supplemented with folic acid. Material and methods.
- Study design. Quasi-experimental study of pretest-posttest design with non-equivalent control group in subjects with substance abuse and healthy subjects. The intervention will consist of the administration of 15 mg of folic acid divided into 3 doses per day. Duplicate oral mucosa samples will be taken from each participant to determine the frequency of micronuclei (MN), nuclear sprouting (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis. (CL) in different temporary events: pre-treatment, at 15 days and 30 days.
This project will be carried out in inmates of a rehabilitation center in El Salto, Jalisco, Mexico, in participants over 18 years of age, chronic drug users (More than 6 months of consumption). The foregoing under prior informed consent, in a convenience sample of 45 chronic drug users, as well as an equivalent sample of 45 healthy individuals without such a history.
- Sample size At convenience. 45 chronic drug users, inmates of a rehabilitation center in Salto, Jalisco, as well as 45 healthy individuals with no history of drug use will be considered.
- Data collection techniques and instruments. It will be done by taking oral cytology, as well as by means of a confidential questionnaire, in the questionnaire sociodemographic data will be collected such as: sex, age, profession, schooling, as well as information related to the consumption of psychoactive substances such as: tobacco, marijuana, alcohol, inhalants, cocaine and methamphetamines, significant pathological and non-pathological personal history. In addition to data referring to the consumption of a nutritional supplement or vitamin such as folates, B12, C, E, A, lutein or melatonin, or some other antioxidant, medications for pharmacological treatment of chronic disease and/or severe active periodontal disease. Exposure to fertilizers, radiation, heavy metals, as well as place of residence to rule out that they live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas). Likewise, a physical examination of the oral cavity will be carried out by a dentist. All of the above in order to identify pathologies that have been shown to generate bias in the results obtained.
Folic acid will be used in the intervention stage in 5 mg tablets, box with 20 tablets, under the trade name Colicid from Bruluagsa.
---Cyto-genotoxic analysis by micronuclei in exfoliated cells of oral mucosa. The cytogenotoxic effect generated by the drugs will be evaluated, as well as the effect conferred to the administration of folic acid on the presentation of nuclear abnormalities associated with cytogenotoxic damage in chronic drug users.
In supplemented and non-supplemented individuals, through the oral mucosa cell micronucleus bioassay, duplicate samples will be obtained from each individual, spread on slides and stained with specific staining of nucleic acids (NA), frequency of micronuclei (MN), nuclear buds (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis (CL).
---Data management and analysis The analysis of the data will be carried out in the GraphPad 9.2.0 program for Windows. For the continuous quantitative variables, the data will be presented with measures of central tendency and dispersion: mean and standard deviation. For the ordinal quantitative variables, they will be presented in frequencies and percentages, for the comparison of frequencies between sexes and age groups with the Fisher X2 test considering a p < 0.05.
The statistical analysis to find differences between the groups will be carried out by means of the T test and for the ordinal variables it will be calculated by means of Chi2.
- Conditions
- Drug Abuse, Genotoxicity
- Being tested
- Folic Acid 5 MG
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid 5 MGDrug
Also called folic acid 5mg cilocid bruluagsa
Folic acid 5mg tablets will be administered orally every 8 hours then samples from buccal mucosa will be taken 15 days and 30 days after suplementation.
| Study group | Role | What they receive |
|---|---|---|
| Basal | No intervention | Samples will be taken to participants. |
| 15 days folate suplementation | Experimental | 5mg tablets of folic acid will be given to participants every 8 hours for a period of 15 days, then samples are to be taken in duplicate for each individual. Receives: Drug: Folic Acid 5 MG |
| 30 days folate suplementatio | Experimental | 5mg tablets of folic acid will be given to participants every 8 hours fora a period of 30 days, then samples are to be taken in duplicate for each individual. Receives: Drug: Folic Acid 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micronucleated cells in 2000 cells
Frequency of micronucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a micronucleated cell has a main nucleus and a smaller one no larger than a third the size of the main nucleus.
Measured: 1 month
Binucleated cells
Frequency of binucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a binucleated cell has two nuclei.
Measured: 1 month
Karyorrhexis
Frequency of karyorrhexis cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyorrhexis: cells that appear to have an striated or fragmented nucleus
Measured: 1 month
Karyolysis
Frequency of karyolysis will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyolysis: cells that have lost their nucleus.
Measured: 1 month
Pycnotic nucleus
Frequency of pycnotic cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Pycnotic cells: appear to have a very dense, brighter, and smaller nucleus, approximately one third of the original
Measured: 1 month
Nuclear buds
Frequency of nuclear budding will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Nuclear bud: a small portion of the genetic material connected through a nucleoplasmic bridge to a main nucleus.
Measured: 1 month
Condensed chromatin
Frequency of condensed chromatin will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Condensed chromatin: where genetic material can be seen in the nuclei.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental study, pretest-posttest design with no control group. equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Tonalá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA GUADALUPE SANCHEZ PARADA, Centro Universitario de Tonalá
- Investigators
- Guadalupe Sanchez, PhD, Principal investigator, Centro Universitario de Tonalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712044
- Sponsor's protocol ID
- F-2022-004
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.
PubMed 19444240Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4.
PubMed 24778463
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Folic Acid Supplementation on the Presentation of Nuclear Abnormalities Associated With Cytogenotoxic Damage Induced by Chronic Drug Use.
- ClinicalTrials.gov ID
- NCT05712044
- Acronym / sponsor ID
- F-2022-004
- Conditions
- Drug Abuse, Genotoxicity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centro Universitario de TonaláUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 3 Feb 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.
Background: Multiple studies have pointed to the harmful potential of licit and illicit drugs.
as agents associated with neoplastic processes and other non-communicable diseases, for which reason It has become a problem of global size. Objective: The central objective is to determine the cytogenotoxic damage in the oral mucosa of people with chronic drug use, as well as establishing the therapeutic effect of acid administration folic on said damage. Methodology: Quasi-experimental study, pretest-posttest design with no control group.
equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents. Resources and infrastructure: The study will be carried out in the pharmacology laboratory of the Center University of Tonalá, who will make their equipment and reagents available. Group experience: The research group has over a decade of experience in the development of projects related to mutagenesis and cyto-genotoxic agents.
Development time: The project will be developed from February 2023 to August of 2023
Detailed description
Objectives.
- General Objective. To determine the effect of folic acid supplementation on the presentation of nuclear abnormalities associated with cytogenotoxic damage in healthy subjects and chronic drug users.
- Specific objectives.
- Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group.
- To compare baseline cytogenotoxic damage determinations with subsequent damage determinations, at 15 and 30 days, in chronic drug users supplemented with folic acid. Material and methods.
- Study design. Quasi-experimental study of pretest-posttest design with non-equivalent control group in subjects with substance abuse and healthy subjects. The intervention will consist of the administration of 15 mg of folic acid divided into 3 doses per day. Duplicate oral mucosa samples will be taken from each participant to determine the frequency of micronuclei (MN), nuclear sprouting (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis. (CL) in different temporary events: pre-treatment, at 15 days and 30 days.
This project will be carried out in inmates of a rehabilitation center in El Salto, Jalisco, Mexico, in participants over 18 years of age, chronic drug users (More than 6 months of consumption). The foregoing under prior informed consent, in a convenience sample of 45 chronic drug users, as well as an equivalent sample of 45 healthy individuals without such a history.
- Sample size At convenience. 45 chronic drug users, inmates of a rehabilitation center in Salto, Jalisco, as well as 45 healthy individuals with no history of drug use will be considered.
- Data collection techniques and instruments. It will be done by taking oral cytology, as well as by means of a confidential questionnaire, in the questionnaire sociodemographic data will be collected such as: sex, age, profession, schooling, as well as information related to the consumption of psychoactive substances such as: tobacco, marijuana, alcohol, inhalants, cocaine and methamphetamines, significant pathological and non-pathological personal history. In addition to data referring to the consumption of a nutritional supplement or vitamin such as folates, B12, C, E, A, lutein or melatonin, or some other antioxidant, medications for pharmacological treatment of chronic disease and/or severe active periodontal disease. Exposure to fertilizers, radiation, heavy metals, as well as place of residence to rule out that they live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas). Likewise, a physical examination of the oral cavity will be carried out by a dentist. All of the above in order to identify pathologies that have been shown to generate bias in the results obtained.
Folic acid will be used in the intervention stage in 5 mg tablets, box with 20 tablets, under the trade name Colicid from Bruluagsa.
---Cyto-genotoxic analysis by micronuclei in exfoliated cells of oral mucosa. The cytogenotoxic effect generated by the drugs will be evaluated, as well as the effect conferred to the administration of folic acid on the presentation of nuclear abnormalities associated with cytogenotoxic damage in chronic drug users.
In supplemented and non-supplemented individuals, through the oral mucosa cell micronucleus bioassay, duplicate samples will be obtained from each individual, spread on slides and stained with specific staining of nucleic acids (NA), frequency of micronuclei (MN), nuclear buds (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis (CL).
---Data management and analysis The analysis of the data will be carried out in the GraphPad 9.2.0 program for Windows. For the continuous quantitative variables, the data will be presented with measures of central tendency and dispersion: mean and standard deviation. For the ordinal quantitative variables, they will be presented in frequencies and percentages, for the comparison of frequencies between sexes and age groups with the Fisher X2 test considering a p < 0.05.
The statistical analysis to find differences between the groups will be carried out by means of the T test and for the ordinal variables it will be calculated by means of Chi2.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Quasi-experimental study, pretest-posttest design with no control group. equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents.
| Arm | Type | Receives |
|---|---|---|
| Basal | No intervention | –Samples will be taken to participants. |
| 15 days folate suplementation | Experimental | Drug: Folic Acid 5 MG5mg tablets of folic acid will be given to participants every 8 hours for a period of 15 days, then samples are to be taken in duplicate for each individual. |
| 30 days folate suplementatio | Experimental | Drug: Folic Acid 5 MG5mg tablets of folic acid will be given to participants every 8 hours fora a period of 30 days, then samples are to be taken in duplicate for each individual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Having used legal and illegal drugs.
- Men or women without diseases
Key exclusion criteria (7 listed)
- People who at the moment of the study or 3 months before:
- Have consumed any dietary supplement or vitamin such as folates, B12,
- C, E, A, lutein or melatonin, or some other antioxidant, medications for
- pharmacological treatment of chronic disease and/or periodontal disease
- severe active.
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 |
|---|---|---|
| Folic Acid 5 MGAlso: folic acid 5mg cilocid bruluagsaFolic acid 5mg tablets will be administered orally every 8 hours then samples from buccal mucosa will be taken 15 days and 30 days after suplementation. | Drug | 15 days folate suplementation, 30 days folate suplementatio |
Primary outcome
Micronucleated cells in 2000 cells
Time frame: 1 month
Frequency of micronucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a micronucleated cell has a main nucleus and a smaller one no larger than a third the size of the main nucleus.
Binucleated cells
Time frame: 1 month
Frequency of binucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a binucleated cell has two nuclei.
Karyorrhexis
Time frame: 1 month
Frequency of karyorrhexis cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyorrhexis: cells that appear to have an striated or fragmented nucleus
Karyolysis
Time frame: 1 month
Frequency of karyolysis will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyolysis: cells that have lost their nucleus.
Pycnotic nucleus
Time frame: 1 month
Frequency of pycnotic cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Pycnotic cells: appear to have a very dense, brighter, and smaller nucleus, approximately one third of the original
Nuclear buds
Time frame: 1 month
Frequency of nuclear budding will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Nuclear bud: a small portion of the genetic material connected through a nucleoplasmic bridge to a main nucleus.
Condensed chromatin
Time frame: 1 month
Frequency of condensed chromatin will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Condensed chromatin: where genetic material can be seen in the nuclei.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 19444240Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.
- Background: PubMed 24778463Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4.
- 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.
Guadalupe Sanchez, PhD principal investigator
Centro Universitario de Tonalá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid 5 MG in people with Drug Abuse and Genotoxicity, run by Centro Universitario de Tonalá at 1 site in Mexico.
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 3 inclusion and 7 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 3 Feb 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 Mexico. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Gomez, Bachelor (3319955964, alex-gomez96@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micronucleated cells in 2000 cells (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712044, which also lists 2 linked publications.
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 3 Feb 2023.