- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03193944
Vitamin D Supplementation on Metabolic Syndrome Indicators Among Older Adults, Alborz Province, Iran
Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran;
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to find relationships between food insecurity, vitamin D intakes and its impact on metabolic syndrome among older adults in a city in Alborz province in Iran, known as Karaj. This study has 2 parts; the first part is to determine the prevalence of food insecurity and vitamin D deficiency among older adults in Karaj city. The second part is an intervention study examining effects of vitamin D supplementation on metabolic syndrome (diabetes, obesity, hypertension, and dyslipidaemia) among older adults who have at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The first part; the data collection process will be performed in a few stages. The first stage will be to initiate contacting with the health centres in Karaj city to identify the older adults. Appointments will be set after screening the study subjects who will be eligible. Consent will be obtained from those who were eligible. The preliminary information on demographic data, socioeconomics, food insecurity, dietary intake and sunlight exposure will be collected by using a set of questionnaires. The blood sample for measuring serum 25 (OH) D will be taken the same day as questionnaires were filled.
The second stage: The data collection process will be performed in few stages. The first stage will include of contact with health centres in Karaj city to identify the older adults for both groups; intervention and control. Consent will be obtained from those who will eligible. Anthropometric measurement (height, weight, body mass index, and waist circumference), blood pressure measurement, blood taking and three-day food record will be obtained during baseline from all study respondents in the intervention and control groups.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alborz
-
Karaj, Alborz, Iran, Islamic Republic of
- Maryam Zarei
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Food insecure,
- Have fit criteria of metabolic syndrome; (WC>90 cm), obesity (BMI≥30 kg/m2), diabetes (FBS>100 mg/dl), high blood pressure (systolic >135 mmHg and diastolic >85 mmHg) and dyslipidaemia (LDL≥ 240 mg/dl, HDL<40 mg/dl, TC≥ 160 mg/dl; TG≥ 200 mg/dl),
- Vitamin D deficient; serum 25(OH) D level <30 ng/ml,
- No use of vitamin D supplementation before 60 days,
Exclusion Criteria:
- An inability or unwillingness to participate,
- Those who are already taking any type of vitamin D supplements,
- Individuals with a history of allergy,
- Those subjects with serious medical condition such as cancer, heart attack, stroke, and etc.,
- Illness that required corticosteroids or insulin,
- Drugs are known to influence vitamin D level; steroids, anti-acids, oestrogen,
- People with conditions that contradict vitamin D supplementation, for example, a history of hypercalcaemia, hepatic disease or renal stones, sarcoidosis, or malignancy,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention group
Intervention group will receive 50,000 U vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks
|
Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks.
Plus, brochures and pamphlets related to nutrition and health.
Other Names:
|
PLACEBO_COMPARATOR: control group
Control group will receive vitamin D as a placebo.
placebo will be identical in appearance taste and odourless.
|
vitamin D as a placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l.
Time Frame: by 2 months
|
According to the guidline, vitamin D deficiency will improve by taking vitamin D3 by 2 months.
|
by 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction anthropometry (BMI and WC),
Time Frame: by 2 months
|
Reduction of BMI, WC after 2 months intervention by vitamin D3
|
by 2 months
|
Improved Biomarker indicators (lipid profile)
Time Frame: by 2 months
|
Reduction of lipid profiles are important for this research after vitamin D3 intervention.
|
by 2 months
|
Improved Biomarker indicator FBS
Time Frame: by 2 months
|
Reduction of FBS by 2 months intervention via taking vitamin D
|
by 2 months
|
Improved blood pressure
Time Frame: by 2 months
|
Reduction of blood pressure after taking vitamin D for 2 months
|
by 2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zarei, World Health Organization
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Overnutrition
- Nutrition Disorders
- Insulin Resistance
- Hyperinsulinism
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Obesity
- Metabolic Syndrome
- Vitamin D Deficiency
- Metabolic Diseases
- Lipid Metabolism Disorders
- Obesity, Abdominal
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- Abzums.Rec.1395.114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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