NCT01019642

Brief Summary

Randomized, double blind, placebo-controlled clinical trial of vitamin D supplementation (cholecalciferol, 4,000 IU/day for 6 months, in 104 postmenopausal women with type 2 diabetes mellitus. The objective was to evaluate the effect of vitamin D supplementation on C-reactive protein (CRP) and insulin resistance in women with type 2 diabetes mellitus (T2DM). The trial was conducted from March to October 2008 at the Hospital of the Mexican Social Security in Cuernavaca, Mexico.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3 diabetes

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

March 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

November 23, 2009

Last Update Submit

November 23, 2009

Conditions

DiabetesLow-intensity Chronic InflammationInsulin Resistance

Keywords

vitamin DdiabetesC-reactive proteininsulin resistance

Outcome Measures

Primary Outcomes (2)

  • Serum C-reactive protein concentrations, measured by a high-sensitivity assay -nephelometry-.

    3 and 6 months

  • Insulin resistance, measured by HOMA-IR index

    3 and 6 months

Secondary Outcomes (1)

  • Serum 25-OH-vitamin D3 levels

    3 and 6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

Cholecalciferol, 4,000 IU/d for 6 months

Drug: cholecalciferol

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

cholecalciferolDRUG

4,000 IU per day during 6 months. Capsule form.

Vitamin D
placeboDRUG

no active principles given.

Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus w/ \< 10 yrs of diagnosis
  • Postmenopausal
  • Overweight or obesity (BMI \>=25)
  • Treated with metformin

You may not qualify if:

  • BMI \>=40
  • Liver or kidney disease
  • Other important chronic disease: i.e. cancer, autoimmune.
  • Receiving insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano del Seguro Social

Cuernavaca, Morelos, 62450, Mexico

Location

Related Publications (2)

  • Flores M. A role of vitamin D in low-intensity chronic inflammation and insulin resistance in type 2 diabetes mellitus? Nutr Res Rev. 2005 Dec;18(2):175-82. doi: 10.1079/NRR2005104.

    PMID: 19079903BACKGROUND

  • Munoz-Aguirre P, Flores M, Macias N, Quezada AD, Denova-Gutierrez E, Salmeron J. The effect of vitamin D supplementation on serum lipids in postmenopausal women with diabetes: A randomized controlled trial. Clin Nutr. 2015 Oct;34(5):799-804. doi: 10.1016/j.clnu.2014.10.002. Epub 2014 Oct 13.

    PMID: 25453396DERIVED

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Mario E Flores, MD, MSc

    Instituto Nacional de Salud Publica, Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

March 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

ME(1)