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Effect of Vitamin D Supplementation on Inflammatory Markers

Primary Purpose

Vitamin D Deficiency, Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
cholecalciferol (Euro-Pharm International, Canada)
Placebo tablet
Sponsored by
Université d'Auvergne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D, type 2 diabetes, inflammation

Eligibility Criteria

60 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects deficient in vitamin D
  • Subjects having type 2 diabetes
  • Non-obese subjects

Exclusion Criteria:

  • Subjects having hyperparathyroidism
  • Subjects suffering from hepatic disease / kidney disease

Sites / Locations

  • Saint Charles Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment group

Placebo group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline weight at 6 months
weight change
Change from Baseline Body Mass Index (BMI) at 6 months
Body mass index
Change from Baseline waist circumference at 6 months
Waist circumference change
Change from Baseline Percentage of fat at 6 months
Percentage of fat
Change from Baseline Parathyroid hormone (PTH) at 6 months
Parathyroid hormone

Full Information

First Posted
December 13, 2018
Last Updated
December 20, 2018
Sponsor
Université d'Auvergne
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1. Study Identification

Unique Protocol Identification Number
NCT03782805
Brief Title
Effect of Vitamin D Supplementation on Inflammatory Markers
Official Title
Effect of Vitamin D Treatment on Some Inflammatory Markers in Non-obese Lebanese Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
July 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université d'Auvergne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Previous studies have shown that improving vitamin D status among the elderly may lead to an improvement in some inflammatory markers, especially with patients with type 2 diabetes. The aim of our trial is study the effect of vitamin D supplementation on inflammatory markers in patients having type 2 diabetes.
Detailed Description
Vitamin D was shown crucial for insulin secretion and glucose homeostasis. Furthermore, one of the markers of type 2 diabetes is low-grade inflammation, which can be the result of an elevated circulation of cytokines. High amounts of circulating inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) contribute significantly to insulin resistance in muscle and adipose tissues. The aim of this randomized, controlled, double blind study is to examine the effect of vitamin D supplementation on some inflammatory markers in older Lebanese patients having type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Type2 Diabetes
Keywords
vitamin D, type 2 diabetes, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol (Euro-Pharm International, Canada)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablet
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline fasting blood glucose (FBG) at 6 months
Description
FASTING BLOOD GLUCOSE
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 6 months
Description
Homeostatic Model Assessment of Insulin Resistance
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline C-reactive protein (CRP) at 6 months
Description
C-reactive protein
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline Interleukin-6 (IL-6) at 6 months
Description
Interleukin-6
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline TNF-alpha at 6 months
Description
TNF-alpha
Time Frame
baseline and after 6 months of intervention
Secondary Outcome Measure Information:
Title
Change from Baseline weight at 6 months
Description
weight change
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline Body Mass Index (BMI) at 6 months
Description
Body mass index
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline waist circumference at 6 months
Description
Waist circumference change
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline Percentage of fat at 6 months
Description
Percentage of fat
Time Frame
baseline and after 6 months of intervention
Title
Change from Baseline Parathyroid hormone (PTH) at 6 months
Description
Parathyroid hormone
Time Frame
baseline and after 6 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects deficient in vitamin D Subjects having type 2 diabetes Non-obese subjects Exclusion Criteria: Subjects having hyperparathyroidism Subjects suffering from hepatic disease / kidney disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia E Hajj, PhD
Organizational Affiliation
Dr
Official's Role
Study Director
Facility Information:
Facility Name
Saint Charles Hospital
City
Beirut
ZIP/Postal Code
64
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The plan will be shared upon request
Citations:
PubMed Identifier
29945132
Citation
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.
Results Reference
background
PubMed Identifier
30159285
Citation
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.
Results Reference
background
PubMed Identifier
32659891
Citation
El Hajj C, Walrand S, Helou M, Yammine K. Effect of Vitamin D Supplementation on Inflammatory Markers in Non-Obese Lebanese Patients with Type 2 Diabetes: A Randomized Controlled Trial. Nutrients. 2020 Jul 9;12(7):2033. doi: 10.3390/nu12072033.
Results Reference
derived

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Effect of Vitamin D Supplementation on Inflammatory Markers

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