NCT04822038

Brief Summary

Introduction. The thickening fibrotic of the skin in systemic sclerosis (SSc) could reduce endogenous availability of Vitamin D by sun exposition. Vitamin D hypovitaminosis have been described in high prevalence in autoimmune disease as SSc. The cholecalciferol contributes to improve the balance TH1/Th2/Treg in favor anti-inflammation and anti-fibrotic profile. Aim. to analyze the effect(s) of short-term cholecalciferol supplementation on cytokine profile in Th1, Th2, and Treg cells subpopulations in SSc patients. Method. Randomized clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. General characteristics, severity of organ involvement scored by Medsger disease severity scale (MsDSS) and cytokine Th1, Th2 and Treg will be determinate. All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

February 12, 2021

Last Update Submit

April 19, 2021

Conditions

Vitamin D DeficiencyScleroderma, Systemic

Keywords

Scleroderma, SystemicVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Effects of vitamin D supplementation on the Th1, Th2 and Treg cytokine profile in adults with scleroderma and hypovitaminosis D

    To assess whether vitamin D3 supplementation modifies the proportion of cytokines inTh1 (IL-2 (%) / INF-ү (%)), Th2 (IL-4 (%)), Treg (IL-10 (%)) cells, in patients with scleroderma and hypovitaminosis D, by flow cytometry.

    2 years

Secondary Outcomes (3)

  • Vitamin D and cirokines serum levels in scleroderma patients with hypovitaminosis D

    2 years

  • Clinical effects of vitamin D3 supplementation in patients with scleroderma and hypovitaminosis D.

    two months from the recruitment of each individual

  • Association between vitamin D, Th1 (IL-2 / INF-γ), Th2 (IL-4), and Treg (IL-10).

    2 years

Study Arms (2)

Scleroderma patients with hypovitaminosis D and dietary recommendations

ACTIVE COMPARATOR

Patients with scleroderma and hypovitaminosis D who receive dietary recommendations

Other: Dietary recommendations

Scleroderma patients with hypovitaminosis D and Vitamin D supplementation

ACTIVE COMPARATOR

Patients with scleroderma and hypovitaminosis D who receive Vitamin D supplementation

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

5000 UI Vitamin D3 daily by 4 weeks

Also known as: Dietary recommendations
Scleroderma patients with hypovitaminosis D and Vitamin D supplementation
Dietary recommendationsOTHER

Dietary recommendations based on food rich in 25 (OH) vitamin D

Scleroderma patients with hypovitaminosis D and dietary recommendations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scleroderma individuals according to 2013 American College of Rheumatology/European League against Rheumatism (ACR/EULAR 2013) classification criteria for SSc.

You may not qualify if:

  • insufficient data to enable classification
  • any acute bacterial infection
  • abnormal kidney function
  • comorbidity
  • other chronic disease degenerative disease such as diabetes and malignancies
  • subjects who received biological therapy or mycophenolate-mofetil during the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Méxicano del Seguro Social

Mexico City, 02990, Mexico

Location

MeSH Terms

Conditions

Vitamin D DeficiencyScleroderma, Systemic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The MD who processed the data and molecular proceedings unknown the intervention in each individual.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Research Division

Study Record Dates

First Submitted

February 12, 2021

First Posted

March 30, 2021

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations

ME(1)