Vitamin D Supplementation on Metabolic Syndrome Indicators Among Older Adults, Alborz Province, Iran
Condition: Vitamin D Deficiency; Diabetes Mellitus; Hypertension; Lipid Metabolism Disorders; Obesity, Abdominal
MeSH terms: Metabolic Syndrome; Vitamin D Deficiency; Metabolic Diseases; Lipid Metabolism Disorders; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      General objective: To assess the effect of vitamin D supplementation on metabolic syndrome
      among food insecure and vitamin D deficient older adults in Karaj city, Alborz province in
      Iran. A two-arm randomised controlled trial (RCT) will be conducted by recruiting
      participants. Inclusion Criteria: Food insecure, metabolic syndrome; Vitamin D deficiency
      Exclusion Criteria: 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., Intervention group: The intervention will start from
      10 of May 2017 to 11 of July 2017 for 2 months. The intervention group will receive 50,000 U
      vitamin D3 per week (equivalent to 1,250 μg) for 8 weeks plus pamphlets and brochures about
      nutrition and health at the beginning of the study. Control group: The respondents in control
      group will receive placebo plus brochures and pamphlets related to nutrition and health at
      the beginning of the study. The data collection process will identify the older adults for
      both groups; intervention and control. Consent will be obtained from those who are 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. Primary Output: Achieving
      25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l. Secondary Output: Reduction
      anthropometry (body mass index (BMI) and waist circumference (WC), Improved Biomarkers
      indicators (lipid profile, fasting blood fast), improved blood pressure before and after
      intervention.
    

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.
    

Intervention name(s): D-vitin, soft gelatin capsule (vitamin D3,50000 IU); Placebo vitamin D3
Intervention type(s): Drug; Drug
Intervention description(s): Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health.; vitamin D as a placebo
Other intervention name(s): cholecalciferol,
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A detailed explanation on research design, location and population, sampling technique, sample size, instrument, data collection, data analysis and potential limitations of the study are outlined in the following sections. 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 has at least have risk factors of metabolic syndrome, food insecure and vitamin D deficient. The intervention group will receive vitamin D supplementation 50000 IU for 8 weeks.
Masking: None (Open Label)
Primary purpose: Treatment