Clinical trial NCT06101589: Effect of Vitamin D Supplementation on Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu Kashmir
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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Lead sponsor: University of the Punjab
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 60 years.
2. Resident of District Haveli, Azad Kashmir for more than last 1 year.
3. Consent to participate in the study.
4. Exposure to war-related stressors (self-reported).

Exclusion Criteria:

1. Age below 18 or above 60 years
2. Ingestion of vit D 200,000 IU in last 3 months.
3. Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
4. Residents outside of District Haveli.
5. Baseline corrected serum calcium concentration \>2.65 mmol/L
6. Unwillingness to provide informed consent.
7. Medical conditions or medication use affecting vitamin D metabolism.
8. Pregnant or lactating mothers
9. On anti-tuberculosis medicines
10. HIV infection

Primary outcomes:
measure: Blood pressure
timeFrame: 4 months
measure: lipid profile
timeFrame: 4 months
measure: body mass index BMI
timeFrame: 4 months
Secondary outcomes:
measure: Serum concentration of vitamin D for the assessment and effect on the allostatic load and chronic stress among the residents of line of control.
timeFrame: 4 months
measure: Hip waist ratio (HRR) cm2
timeFrame: 4 months
Other outcomes:
Locations:
city: Haveli
country: Pakistan
facility: District Headquarter Hospital Haveli
state: Azad Jammu And Kashmir
Study officials:
affiliation: University of the Punjab
name: jawwad AF kayani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amrein K, Scherkl M, Hoffmann M, Neuwersch-Sommeregger S, Kostenberger M, Tmava Berisha A, Martucci G, Pilz S, Malle O. Vitamin D deficiency 2.0: an update on the current status worldwide. Eur J Clin Nutr. 2020 Nov;74(11):1498-1513. doi: 10.1038/s41430-020-0558-y. Epub 2020 Jan 20.
citation: Bunting BA, Smith BH, Sutherland SE. The Asheville Project: clinical and economic outcomes of a community-based long-term medication therapy management program for hypertension and dyslipidemia. J Am Pharm Assoc (2003). 2008 Jan-Feb;48(1):23-31. doi: 10.1331/JAPhA.2008.07140.
citation: Casseb GAS, Kaster MP, Rodrigues ALS. Potential Role of Vitamin D for the Management of Depression and Anxiety. CNS Drugs. 2019 Jul;33(7):619-637. doi: 10.1007/s40263-019-00640-4.