Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2025-12-16 @ 10:22 PM
Study NCT ID:
NCT06101589
Status:
None
Last Update Posted:
2024-05-14 00:00:00
First Post:
2023-10-12 00:00:00
Brief Title:
Effect of Vitamin D Supplementation on Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu Kashmir
Sponsor:
University of the Punjab
Organization:
University of the Punjab
Study Overview
Official Title:
Effect of Vitamin D Supplementation on the Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu and Kashmir. "Double Blind Randomized Placebo-controlled Trial"
Status:
None
Status Verified Date:
2024-05
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:
The aim of this research is to fully comprehend the complex relationship between chronic stress, physiological dysregulation (as measured by allostatic load), and the potential impact of vitamin D supplementation on psychological well-being and physical health in a conflict-affected population.TRIAL ENDPOINTS Primary endpoint The primary outcome will be the Allostatic load after the 3 supplementation doses of study medication.
Secondary Efficacy Endpoints Serum concentration of vitamin D, HbA1C, lipid profile (HDL and LDL), serum cortisol and C reactive proteins after 4 months.
Any change in the Biophysical parameters (blood pressure (BP), heart rate (HR), body mass index (BMI) and hip waist ratio (HRR) after 4 months Chronic stress reduction after 4 months (dose effect) and determinants identification by sub group analysis.
Residents of warzone areas, such as District Haveli in Azad Kashmir, endure persistent exposure to chronic stressors resulting from conflict-related violence, displacement, and traumatic events. This chronic stress not only takes a toll on their mental health but also triggers physiological dysregulation across multiple systems, contributing to an increased allostatic load. Furthermore, the prevalent deficiency of vitamin D, exacerbated by limited sunlight exposure and disrupted food supplies, poses additional health risks in this population. Despite these challenges, there is a notable lack of comprehensive research investigating the determinants of allostatic load in the context of chronic stress and the potential ameliorative effects of vitamin D supplementation. Addressing this gap is crucial for understanding the intricate interplay between stress, physiological health, and potential interventions, thereby contributing to the well-being and resilience of residents in conflict-affected regions.STUDY DESIGN/STUDY PLACE:
The study will employ a It will be a double blinded, parallel individually randomized control trial and will be conducted in District Haveli, Azad Kashmir, armed conflicted area affected by conflict-related stressors.
STUDY POPULATION:
The study will include adult male/female) age (18-60 years) residents of District Haveli, Azad Kashmir, who have been exposed to war-related stressors, violence, and displacement.
SAMPLE SIZE Assuming that 60% of the participants in the control group arm would attain \>30% of the baseline vitamin D status at 6 months, we calculated that a total of 94 participants (47 per arm) would need to complete follow-up in order to detect a 25% absolute increase (to 85%) in the proportion of patients attaining \>30% vitamin D level at 6 months in the intervention arm with 80% power at the5% significance level(Giacomet et al., 2014). This number will be inflated to a total of 114 allow attrition due to death and loss to follow up. There will be interim analysis in the plan.
SAMPLING TECHNIQUE: The multi-stage cluster sample strategy is ideal for research done in places with geographical dispersion, limited access, and community-specific characteristics. STUDY TOOL:
The study will utilize a combination of validated questionnaires and physiological measurements to collect data.
DATA COLLECTION PROCESS; To reduce the burden of data collectors and make data collection process easier and accessible, data will be collected on google forms/kobo tool. Data collector team will be equipped with android mobile/tab, where kobo tool will be installed. Data will be gathered in offline mode as some of the bordering area, may not have access to internet, once team is back from field will synchronized the data in online mode. This way we will have complete data set at the same time to check quality and completeness, and remove errors through virtual backstopping.
Secondary Efficacy Endpoints Serum concentration of vitamin D, HbA1C, lipid profile (HDL and LDL), serum cortisol and C reactive proteins after 4 months.
Any change in the Biophysical parameters (blood pressure (BP), heart rate (HR), body mass index (BMI) and hip waist ratio (HRR) after 4 months Chronic stress reduction after 4 months (dose effect) and determinants identification by sub group analysis.
Residents of warzone areas, such as District Haveli in Azad Kashmir, endure persistent exposure to chronic stressors resulting from conflict-related violence, displacement, and traumatic events. This chronic stress not only takes a toll on their mental health but also triggers physiological dysregulation across multiple systems, contributing to an increased allostatic load. Furthermore, the prevalent deficiency of vitamin D, exacerbated by limited sunlight exposure and disrupted food supplies, poses additional health risks in this population. Despite these challenges, there is a notable lack of comprehensive research investigating the determinants of allostatic load in the context of chronic stress and the potential ameliorative effects of vitamin D supplementation. Addressing this gap is crucial for understanding the intricate interplay between stress, physiological health, and potential interventions, thereby contributing to the well-being and resilience of residents in conflict-affected regions.STUDY DESIGN/STUDY PLACE:
The study will employ a It will be a double blinded, parallel individually randomized control trial and will be conducted in District Haveli, Azad Kashmir, armed conflicted area affected by conflict-related stressors.
STUDY POPULATION:
The study will include adult male/female) age (18-60 years) residents of District Haveli, Azad Kashmir, who have been exposed to war-related stressors, violence, and displacement.
SAMPLE SIZE Assuming that 60% of the participants in the control group arm would attain \>30% of the baseline vitamin D status at 6 months, we calculated that a total of 94 participants (47 per arm) would need to complete follow-up in order to detect a 25% absolute increase (to 85%) in the proportion of patients attaining \>30% vitamin D level at 6 months in the intervention arm with 80% power at the5% significance level(Giacomet et al., 2014). This number will be inflated to a total of 114 allow attrition due to death and loss to follow up. There will be interim analysis in the plan.
SAMPLING TECHNIQUE: The multi-stage cluster sample strategy is ideal for research done in places with geographical dispersion, limited access, and community-specific characteristics. STUDY TOOL:
The study will utilize a combination of validated questionnaires and physiological measurements to collect data.
DATA COLLECTION PROCESS; To reduce the burden of data collectors and make data collection process easier and accessible, data will be collected on google forms/kobo tool. Data collector team will be equipped with android mobile/tab, where kobo tool will be installed. Data will be gathered in offline mode as some of the bordering area, may not have access to internet, once team is back from field will synchronized the data in online mode. This way we will have complete data set at the same time to check quality and completeness, and remove errors through virtual backstopping.
Detailed Description:
The aim of this research is to fully comprehend the complex relationship between chronic stress physiological dysregulation as measured by allostatic load and the potential impact of vitamin D supplementation on psychological well-being and physical health in a conflict-affected populationTRIAL ENDPOINTS Primary endpoint The primary outcome will be the Allostatic load after the 3 supplementation doses of study medication
Secondary Efficacy Endpoints Serum concentration of vitamin D HbA1C lipid profile HDL and LDL serum cortisol and C reactive proteins after 4 months
Any change in the Biophysical parameters blood pressure BP heart rate HR body mass index BMI and hip waist ratio HRR after 4 months Chronic stress reduction after 4 months dose effect and determinants identification by sub group analysis
Residents of warzone areas such as District Haveli in Azad Kashmir endure persistent exposure to chronic stressors resulting from conflict-related violence displacement and traumatic events This chronic stress not only takes a toll on their mental health but also triggers physiological dysregulation across multiple systems contributing to an increased allostatic load Furthermore the prevalent deficiency of vitamin D exacerbated by limited sunlight exposure and disrupted food supplies poses additional health risks in this population Despite these challenges there is a notable lack of comprehensive research investigating the determinants of allostatic load in the context of chronic stress and the potential ameliorative effects of vitamin D supplementation Addressing this gap is crucial for understanding the intricate interplay between stress physiological health and potential interventions thereby contributing to the well-being and resilience of residents in conflict-affected regionsSTUDY DESIGNSTUDY PLACE
The study will employ a It will be a double blinded parallel individually randomized control trial and will be conducted in District Haveli Azad Kashmir armed conflicted area affected by conflict-related stressors
STUDY POPULATION
The study will include adult malefemale age 18-60 years residents of District Haveli Azad Kashmir who have been exposed to war-related stressors violence and displacement
SAMPLE SIZE Assuming that 60 of the participants in the control group arm would attain 30 of the baseline vitamin D status at 6 months we calculated that a total of 94 participants 47 per arm would need to complete follow-up in order to detect a 25 absolute increase to 85 in the proportion of patients attaining 30 vitamin D level at 6 months in the intervention arm with 80 power at the5 significance levelGiacomet et al 2014 This number will be inflated to a total of 114 allow attrition due to death and loss to follow up There will be interim analysis in the plan
SAMPLING TECHNIQUE The multi-stage cluster sample strategy is ideal for research done in places with geographical dispersion limited access and community-specific characteristics STUDY TOOL
The study will utilize a combination of validated questionnaires and physiological measurements to collect data
DATA COLLECTION PROCESS To reduce the burden of data collectors and make data collection process easier and accessible data will be collected on google formskobo tool Data collector team will be equipped with android mobiletab where kobo tool will be installed Data will be gathered in offline mode as some of the bordering area may not have access to internet once team is back from field will synchronized the data in online mode This way we will have complete data set at the same time to check quality and completeness and remove errors through virtual backstopping
Secondary Efficacy Endpoints Serum concentration of vitamin D HbA1C lipid profile HDL and LDL serum cortisol and C reactive proteins after 4 months
Any change in the Biophysical parameters blood pressure BP heart rate HR body mass index BMI and hip waist ratio HRR after 4 months Chronic stress reduction after 4 months dose effect and determinants identification by sub group analysis
Residents of warzone areas such as District Haveli in Azad Kashmir endure persistent exposure to chronic stressors resulting from conflict-related violence displacement and traumatic events This chronic stress not only takes a toll on their mental health but also triggers physiological dysregulation across multiple systems contributing to an increased allostatic load Furthermore the prevalent deficiency of vitamin D exacerbated by limited sunlight exposure and disrupted food supplies poses additional health risks in this population Despite these challenges there is a notable lack of comprehensive research investigating the determinants of allostatic load in the context of chronic stress and the potential ameliorative effects of vitamin D supplementation Addressing this gap is crucial for understanding the intricate interplay between stress physiological health and potential interventions thereby contributing to the well-being and resilience of residents in conflict-affected regionsSTUDY DESIGNSTUDY PLACE
The study will employ a It will be a double blinded parallel individually randomized control trial and will be conducted in District Haveli Azad Kashmir armed conflicted area affected by conflict-related stressors
STUDY POPULATION
The study will include adult malefemale age 18-60 years residents of District Haveli Azad Kashmir who have been exposed to war-related stressors violence and displacement
SAMPLE SIZE Assuming that 60 of the participants in the control group arm would attain 30 of the baseline vitamin D status at 6 months we calculated that a total of 94 participants 47 per arm would need to complete follow-up in order to detect a 25 absolute increase to 85 in the proportion of patients attaining 30 vitamin D level at 6 months in the intervention arm with 80 power at the5 significance levelGiacomet et al 2014 This number will be inflated to a total of 114 allow attrition due to death and loss to follow up There will be interim analysis in the plan
SAMPLING TECHNIQUE The multi-stage cluster sample strategy is ideal for research done in places with geographical dispersion limited access and community-specific characteristics STUDY TOOL
The study will utilize a combination of validated questionnaires and physiological measurements to collect data
DATA COLLECTION PROCESS To reduce the burden of data collectors and make data collection process easier and accessible data will be collected on google formskobo tool Data collector team will be equipped with android mobiletab where kobo tool will be installed Data will be gathered in offline mode as some of the bordering area may not have access to internet once team is back from field will synchronized the data in online mode This way we will have complete data set at the same time to check quality and completeness and remove errors through virtual backstopping
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?:
None
Is an FDA AA801 Violation?:
None