NCT03008057

Brief Summary

The aim of this study is to determine the effects of vitamin D or placebo for 3 months on the gene expression of glyoxalase enzyme, RAGE, and YKL40 in the peripheral blood mononuclear cell (PBMC) and serum levels of YKL40,AGEs, TNF-α, PAI-1, IL-6, and HbA1c of diabetes type 2 patients.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

4.5 years

First QC Date

December 29, 2016

Last Update Submit

July 15, 2021

Conditions

Type2 Diabetes

Keywords

vitamin DYKL40PAI-1RAGEAGEsglyoxalase enzymeTNF-alphaIL-6Diabetes

Outcome Measures

Primary Outcomes (3)

  • serum HbA1c

    Change frome baseline at 3 months

  • serum fasting insulin

    Change frome baseline at 3 months

  • serum Fasting blood suger,

    Change frome baseline at 3 months

Secondary Outcomes (11)

  • serum AGES

    Change frome baseline at 3 months

  • serum IL6

    Change frome baseline at 3 months

  • serum TNF-alpha

    Change frome baseline at 3 months

  • serum PAI-1

    Change frome baseline at 3 months

  • RAGE gene expression

    Change frome baseline at 3 months

  • +6 more secondary outcomes

Study Arms (2)

vitamin D supplementation

ACTIVE COMPARATOR

patients with type 2 diabetes receive 1 tablet (4000 IU ) vitamin D supplementation, one time a day, for 3 months.

Dietary Supplement: vitamin D

vitamin D placebo

PLACEBO COMPARATOR

patients with type 2 diabetes receive one tablet of vitamin D placebo for 3 months

Dietary Supplement: vitamin D placebo

Interventions

vitamin DDIETARY_SUPPLEMENT

vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months

vitamin D supplementation
vitamin D placeboDIETARY_SUPPLEMENT

vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months

vitamin D placebo

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- diabetic type 2 patients 35-65 years old, body mass index in the range 18.5- 30 ,literate, willingness to participation,avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -

You may not qualify if:

  • people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers,sever change in regular diet and life style,change in type and dosage of regular medication (s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Omidian M, Djalali M, Javanbakht MH, Eshraghian MR, Abshirini M, Omidian P, Alvandi E, Mahmoudi M. Effects of vitamin D supplementation on advanced glycation end products signaling pathway in T2DM patients: a randomized, placebo-controlled, double blind clinical trial. Diabetol Metab Syndr. 2019 Oct 26;11:86. doi: 10.1186/s13098-019-0479-x. eCollection 2019.

    PMID: 31673295DERIVED

  • Omidian M, Mahmoudi M, Abshirini M, Eshraghian MR, Javanbakht MH, Zarei M, Hasani H, Djalali M. Effects of vitamin D supplementation on depressive symptoms in type 2 diabetes mellitus patients: Randomized placebo-controlled double-blind clinical trial. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2375-2380. doi: 10.1016/j.dsx.2019.06.011. Epub 2019 Jun 11.

    PMID: 31405646DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07