Effect of Vitamin D Supplementation on Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu Kashmir

Mental Health Issue Clinical Trial

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"

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06101589
• Other study ID #: D/142/FIMS
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: May 2024
• Source: University of the Punjab
• Contact: jawwad Af kayani, PhD
• Phone: +923129117945
• Email: drjawwadkayani[@]hsa.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 15, 2024
• Est. primary completion date: August 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Dietary Supplement:
• 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3.
5 mg (200,000 IU) vitamin D3 in 1 ml ethyl oleate Pharmaceutical form: Solution of vitamin D3 in ethyl oleate, 0.75% w/v. three doses will be given orally every a month apart.
• Placebo
Olive oil in 1 ml ethyl oleate with no vitamin D3 content

Locations

Country	Name	City	State
Pakistan	District Headquarter Hospital Haveli	Haveli	Azad Jammu And Kashmir

Sponsors (1)

Lead Sponsor	Collaborator
University of the Punjab

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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/s41430-02 — View 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: 10.1 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	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	4 months
Primary	lipid profile	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	4 months
Primary	body mass index BMI	Body mass index (BMI) = 30 kg/m2, and 2 25 to < 30 kg/m2 18 to < 25 kg/m	4 months
Secondary	Serum concentration of vitamin D for the assessment and effect on the allostatic load and chronic stress among the residents of line of control.	Vitamin D level will give us the clue for the supplementation effect and effect on the allostatic load and chronic stress.; vitamin D normal range 30 ng/dl and above vitamin D insufficiency 20-29 ng/dl vitamin D deficiency less than 20 ng/dl	4 months
Secondary	Hip waist ratio (HRR) cm2	Waist hip ratio (women) = 0.85cm2 > 0.80 to < 0.85cm2 = 0.80cm2 Waist hip ratio (men) = 1.0cm2 > 0.95 to < 1.0cm2 = 0.95cm2	4 months