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

NCT06101589 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-14

No results posted yet for this study

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

Conditions

  • Mental Health Issue

Interventions

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.

DIETARY_SUPPLEMENT

Placebo

Olive oil in 1 ml ethyl oleate with no vitamin D3 content

Sponsors & Collaborators

  • University of the Punjab

    lead OTHER

Principal Investigators

  • jawwad AF kayani, PhD · University of the Punjab

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2024-08-25
Completion
2024-09-15

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06101589 on ClinicalTrials.gov