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

NCT03193944 | Completed Phase 2 DMC

• 1 other identifier: Abzums.Rec.1395.114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Achieving 25 (OH) D upper than insufficient serum 25(OH) D level >30 ng/l.

  According to the guidline, vitamin D deficiency will improve by taking vitamin D3 by 2 months.

  by 2 months

Secondary Outcomes (4)

• Reduction anthropometry (BMI and WC),

  by 2 months

• Improved Biomarker indicators (lipid profile)

  by 2 months

• Improved Biomarker indicator FBS

  by 2 months

• Improved blood pressure

  by 2 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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)

control group

PLACEBO COMPARATOR

Control group will receive vitamin D as a placebo. placebo will be identical in appearance taste and odourless.

Drug: Placebo vitamin D3

Interventions

D-vitin, soft gelatin capsule (vitamin D3,50000 IU) DRUG

Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health.

Also known as: cholecalciferol,

Intervention group

Placebo vitamin D3 DRUG

vitamin D as a placebo

control group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: Aged from 60 to 80 years old,
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Alborz Medical University: lead
• Universiti Putra Malaysia: collaborator

Study Sites (1)

Maryam Zarei

Karaj, Alborz Province, Iran

Location

MeSH Terms

Conditions

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

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Obesity; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Zarei

  World Health Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 21, 2017
• Study Start: February 10, 2017
• Primary Completion: May 10, 2017
• Study Completion: July 10, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)