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Outcome Measures

Primary Outcomes (5)

Change from Baseline fasting blood glucose (FBG) at 6 months
FASTING BLOOD GLUCOSE
baseline and after 6 months of intervention
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
Homeostatic Model Assessment of Insulin Resistance
baseline and after 6 months of intervention
Change from Baseline C-reactive protein (CRP) at 6 months
C-reactive protein
baseline and after 6 months of intervention
Change from Baseline Interleukin-6 (IL-6) at 6 months
Interleukin-6
baseline and after 6 months of intervention
Change from Baseline TNF-alpha at 6 months
TNF-alpha
baseline and after 6 months of intervention

Secondary Outcomes (5)

Change from Baseline weight at 6 months
baseline and after 6 months of intervention
Change from Baseline Body Mass Index (BMI) at 6 months
baseline and after 6 months of intervention
Change from Baseline waist circumference at 6 months
baseline and after 6 months of intervention
Change from Baseline Percentage of fat at 6 months
baseline and after 6 months of intervention
Change from Baseline Parathyroid hormone (PTH) at 6 months
baseline and after 6 months of intervention

Study Arms (2)

treatment group

EXPERIMENTAL

Group receiving a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) to be taken 3 times a week for a period of six months.

Dietary Supplement: cholecalciferol (Euro-Pharm International, Canada)

Placebo group

PLACEBO COMPARATOR

Group receiving a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months

Dietary Supplement: Placebo tablet

Interventions

cholecalciferol (Euro-Pharm International, Canada)Dietary supplement

The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months

treatment group

Placebo tabletDietary supplement

The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months

Related Publications (3)

Yu Y, Tian L, Xiao Y, Huang G, Zhang M. Effect of Vitamin D Supplementation on Some Inflammatory Biomarkers in Type 2 Diabetes Mellitus Subjects: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ann Nutr Metab. 2018;73(1):62-73. doi: 10.1159/000490358. Epub 2018 Jun 26.

PMID: 29945132BACKGROUND

Safarpour P, Vafa MR, Amiri F, Janani L, Noorbakhsh M, Rajabpour Nikoo E, Sadeghi H. A double blind randomized clinical trial to investigate the effect of vitamin D supplementation on metabolic and hepato-renal markers in type 2 diabetes and obesity. Med J Islam Repub Iran. 2018 Apr 28;32:34. doi: 10.14196/mjiri.32.34. eCollection 2018.

PMID: 30159285BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyDiabetes Mellitus, Type 2Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPathologic Processes

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

PARTICIPANT, INVESTIGATOR

Masking Details

Neither the investigator nor the subjects were aware of the group allocation; the pharmacist (in charge of the placebo tablets as well as the packing and coding of the supplements) was the only person to know to which group each participant belonged.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: In this randomized, controlled, double blind study, participants were randomized (using the simple randomization method) to receive either a supplement of 10,000 IU of cholecalciferol (Euro-Pharm International, Canada) or a placebo tablet (containing microcrystalline cellulose: 66.3%, starch: 33.2%, magnesium stearate: 0.5%, per serving) to be taken 3 times a week for a period of six months

Sponsor Type

OTHER

Responsible Party

SPONSOR

Effect of Vitamin D Supplementation on Inflammatory Markers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (2)

treatment group

Placebo group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (2)

treatment group

Placebo group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations