Effect of Vitamin D Supplementation on Inflammatory Markers

NCT03782805 | Completed DMC

• 1 other identifier: 222222
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Type2 Diabetes

Keywords

vitamin D, type 2 diabetes, inflammation

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 tablet 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

Eligibility Criteria

• Age: 60 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université d'Auvergne: lead

Study Sites (1)

Saint Charles Hospital

Beirut, 64, Lebanon

Location

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: 29945132 BACKGROUND

• 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: 30159285 BACKGROUND

• 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.

  PMID: 32659891 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Diabetes Mellitus, Type 2; Inflammation

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; 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

• Cynthia E Hajj, PhD

  Dr

  STUDY DIRECTOR

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 20, 2018
• Study Start: May 9, 2018
• Primary Completion: June 7, 2018
• Study Completion: July 9, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)