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"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
FULL 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"
SHORT TITLE Effect of vitamin D supplementation on allostatic load and chronic stress along line of control in azad Jammu and Kashmir PROTOCOL/VERSION DATE 5th August 2023 METHODOLOGY "Double blind randomized placebo-controlled trial"
STUDY DURATION 1 year STUDY CENTRES 1. District head quarter hospital haveli district Azad Kashmir 2. Rural health center (RHC) Khursheed Abad, 3. Basic health unit (BHU) Kirni Mandhaar and 4. First aid post (FAP) Chirikot. Main Objectives -To determine whether high-dose oral vitamin D supplementation effects allostatic load and chronic stress of the residents of line of control haveli district Azad Jammu and Kashmir (primary outcome)
- To assess the prevalence and determinants of allostatic load and chronic stress among the residents of line of control (secondary outcome factors analysis).
- To look into the relationship between chronic stress and vital clinical markers as blood pressure, BMI, and lipid profile in participants from line of control.
- To determine whether this intervention is safe and well-tolerated by study participants (secondary outcomes, safety) No. of Participants 120 Statistical Methodology and Analysis The collected data will be analysed using appropriate statistical techniques: Descriptive statistics will summarize participant characteristics, chronic stress, psychological well-being, physical health indicators, and baseline vitamin D levels. Inferential statistics, such as t-tests, ANOVA, and regression analysis, will be used to examine relationships between chronic stress, allostatic load, vitamin D supplementation, and health outcomes. Subgroup analyses will explore potential interactions based on demographic variables
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double blind study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years.
- •Resident of District Haveli, Azad Kashmir for more than last 1 year.
- •Consent to participate in the study.
- •Exposure to war-related stressors (self-reported).
排除标准
- •Age below 18 or above 60 years
- •Ingestion of vit D 200,000 IU in last 3 months.
- •Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
- •Residents outside of District Haveli.
- •Baseline corrected serum calcium concentration >2.65 mmol/L
- •Unwillingness to provide informed consent.
- •Medical conditions or medication use affecting vitamin D metabolism.
- •Pregnant or lactating mothers
- •On anti-tuberculosis medicines
- •HIV infection
结局指标
主要结局
Blood pressure
时间窗: 4 months
Allostatic load is a measure of physiological dysregulation caused by the accumulated impact of chronic stress on the body. Systolic pressure ≥ 150 mmHg, and 120 to 149 mmHg \< 120 mmHg Diastolic blood pressure ≥ 90 mmHg, 80 to 89 mmHg \< 80 mmHg
lipid profile
时间窗: 4 months
Total cholesterol ≥ 240 mg/dL, 200 to 239 mg/dL \< 200 mg/dL HDL \< 40 mg/dL 40 to 59 mg/dL, \> 60 mg/dL Total /HDL cholesterol ≥ 6 5 to \< 6 \< 5
body mass index BMI
时间窗: 4 months
Body mass index (BMI) ≥ 30 kg/m2, and 2 25 to \< 30 kg/m2 18 to \< 25 kg/m
次要结局
- Serum concentration of vitamin D for the assessment and effect on the allostatic load and chronic stress among the residents of line of control.(4 months)
- Hip waist ratio (HRR) cm2(4 months)
研究者
Jawwad Afzal Kayani
principal investigator
University of the Punjab