Mental Health IssueNCT06101589
Effect of Vitamin D Supplementation on Allostatic Load and Chronic Stress Along Line of Control in Azad Jammu Kashmir
A study testing 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3. in people with Mental Health Issue, run by University of the Punjab at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2024to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Medical conditions or medication use affecting vitamin D metabolism.
- Pregnant or lactating mothers
- On anti-tuberculosis medicines
- HIV infection
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District Headquarter Hospital Haveli
Haveli, Azad Kashmir, 12201
About this study
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"
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"
Read more
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
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3., Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
Olive oil in 1 ml ethyl oleate with no vitamin D3 content
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
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
Measured: 4 months
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start15 May 2024 (estimated)
- Primary completion25 Aug 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jawwad Afzal Kayani, University of the Punjab
- Investigators
- jawwad AF kayani, PhD, Principal investigator, University of the Punjab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101589
- Sponsor's protocol ID
- D/142/FIMS
- Status last verified
- May 2024
- First submitted
- 12 Oct 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31959942Bunting 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.
PubMed 18192127Casseb 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.
PubMed 31093951
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06101589
- Acronym / sponsor ID
- D/142/FIMS
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 25 Aug 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm in which we will give the active Vitamin D to participants | Experimental | Dietary Supplement: 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3.the intervention will be the Vitamin D in its active form 200,00 IU 25(OH)D3.route of administration is oral. |
| placebo arm in which we will give the placebo | Placebo comparator | Dietary Supplement: Placeboolive oil will be the placebo medicine. the placebo medicine have similar taste and quantity. the route of administration is oral. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | experimental arm in which we will give the active Vitamin D to participants |
| PlaceboOlive oil in 1 ml ethyl oleate with no vitamin D3 content | Dietary supplement | placebo arm in which we will give the placebo |
Primary outcome
Blood pressure
Time frame: 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
Time frame: 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
Time frame: 4 months
Body mass index (BMI) ≥ 30 kg/m2, and 2 25 to < 30 kg/m2 18 to < 25 kg/m
2 secondary outcomes
Serum concentration of vitamin D for the assessment and effect on the allostatic load and chronic stress among the residents of line of control.
Time frame: 4 months
Hip waist ratio (HRR) cm2
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Results publication: PubMed 31959942Amrein 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.
- Results publication: PubMed 18192127Bunting 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.
- Results publication: PubMed 31093951Casseb 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jawwad AF kayani, PhD principal investigator
University of the Punjab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25 hydroxy cholecalciferol (Vitamin D) /25(OH)D3. in people with Mental Health Issue, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jawwad Af kayani, PhD (+923129117945, drjawwadkayani@hsa.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101589, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.