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Effect of Vitamin D Supplementation on Inflammatory Markers

NCT ID: NCT03782805

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2018-07-09

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency Type2 Diabetes

Keywords

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vitamin D, type 2 diabetes, inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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treatment group

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 Type EXPERIMENTAL

cholecalciferol (Euro-Pharm International, Canada)

Intervention Type 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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type 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

Interventions

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cholecalciferol (Euro-Pharm International, Canada)

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

Placebo tablet

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

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université d'Auvergne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cynthia E Hajj, PhD

Role: STUDY_DIRECTOR

Dr

Locations

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Saint Charles Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type BACKGROUND
PMID: 29945132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30159285 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32659891 (View on PubMed)

Other Identifiers

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222222

Identifier Type: -

Identifier Source: org_study_id