Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05712044
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-03
First Post:
2023-01-02
Brief Title:
Effect of Folic Acid on the Presentation of Nuclear Abnormalities in People With a History Drug Abuse
Sponsor:
Centro Universitario de Tonalá
Organization:
Centro Universitario de Tonalá
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
1 Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group
2 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 andor 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 920 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 005
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
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
1 Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group
2 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 andor 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 920 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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None