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

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.

Conditions

• Vitamin D Deficiency
• Diabetes Mellitus
• Hypertension
• Lipid Metabolism Disorders
• Obesity, Abdominal

Interventions

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.

DRUG

Placebo vitamin D3

vitamin D as a placebo

Sponsors & Collaborators

• Universiti Putra Malaysia

  collaborator OTHER

• Alborz Medical University

  lead OTHER_GOV

Principal Investigators

• Zarei · World Health Organization

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-02-10

Primary Completion

2017-05-10

Completion

2017-07-10

Countries

• Iran

Study Locations