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

January 12, 2018 updated by: Maryam Zarei, Alborz Medical University

Vitamin D Supplementation on Metabolic Syndrome Indicators Among Food Insecure, Vitamin D Deficient Older Adults in Karaj City, Alborz Province, Iran;

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alborz Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zarei, World Health Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Abzums.Rec.1395.114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Conditions

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