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Vitamin D Supplementation on Metabolic Syndrome Indicators Among Older Adults, Alborz Province, Iran

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ClinicalTrials.gov Identifier: NCT03193944
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
Universiti Putra Malaysia
Information provided by (Responsible Party):
Maryam Zarei, Alborz Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Diabetes Mellitus Hypertension Lipid Metabolism Disorders Obesity, Abdominal Drug: D-vitin, soft gelatin capsule (vitamin D3,50000 IU) Drug: Placebo vitamin D3 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Official Title: Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran;
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine


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
Drug: D-vitin, soft gelatin capsule (vitamin D3,50000 IU)
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 Name: cholecalciferol,

Placebo Comparator: control group
Control group will receive vitamin D as a placebo. placebo will be identical in appearance taste and odourless.
Drug: Placebo vitamin D3
vitamin D as a placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reduction anthropometry (BMI and WC), [ Time Frame: by 2 months ]
    Reduction of BMI, WC after 2 months intervention by vitamin D3

  2. Improved Biomarker indicators (lipid profile) [ Time Frame: by 2 months ]
    Reduction of lipid profiles are important for this research after vitamin D3 intervention.

  3. Improved Biomarker indicator FBS [ Time Frame: by 2 months ]
    Reduction of FBS by 2 months intervention via taking vitamin D

  4. Improved blood pressure [ Time Frame: by 2 months ]
    Reduction of blood pressure after taking vitamin D for 2 months



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Aged from 60 to 80 years old,
Accepts Healthy Volunteers:   Yes
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193944


Locations
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Iran, Islamic Republic of
Maryam Zarei
Karaj, Alborz, Iran, Islamic Republic of
Sponsors and Collaborators
Alborz Medical University
Universiti Putra Malaysia
Investigators
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Principal Investigator: Zarei World Health Organization

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Responsible Party: Maryam Zarei, Principal investigator, Alborz Medical University
ClinicalTrials.gov Identifier: NCT03193944     History of Changes
Other Study ID Numbers: Abzums.Rec.1395.114
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Vitamin D Deficiency
Metabolic Diseases
Lipid Metabolism Disorders
Obesity, Abdominal
Glucose Metabolism Disorders
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Obesity
Overnutrition
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents