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

NCT06101589 | Not Yet Recruiting DMC

• 1 other identifier: D/142/FIMS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• 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

Study Arms (2)

experimental arm in which we will give the active Vitamin D to participants

EXPERIMENTAL

the intervention will be the Vitamin D in its active form 200,00 IU 25(OH)D3.route of administration is oral.

Dietary Supplement: 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3.

placebo arm in which we will give the placebo

PLACEBO COMPARATOR

olive oil will be the placebo medicine. the placebo medicine have similar taste and quantity. the route of administration is oral.

Dietary Supplement: Placebo

Interventions

25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3. DIETARY_SUPPLEMENT

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.

experimental arm in which we will give the active Vitamin D to participants

Placebo DIETARY_SUPPLEMENT

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

placebo arm in which we will give the placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Punjab: lead

Study Sites (1)

District Headquarter Hospital Haveli

Haveli, Azad Kashmir, 12201, Pakistan

Location

Related 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/s41430-020-0558-y. Epub 2020 Jan 20.

  PMID: 31959942 RESULT

• 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.

  PMID: 18192127 RESULT

• 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.

  PMID: 31093951 RESULT

MeSH Terms

Interventions

Vitamin D; Calcifediol

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• jawwad AF kayani, PhD

  University of the Punjab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jawwad Af kayani, PhD

CONTACT

+923129117945; drjawwadkayani@hsa.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 26, 2023
• Study Start: May 15, 2024
• Primary Completion: August 25, 2024
• Study Completion: September 15, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)