NCT02906319

Brief Summary

The purpose of this study is to determine the association between serum 25-hydroxyvitamin D and HbA1c levels in diabetic patients with chronic kidney disease. The investigators hypothesized that serum 25-hydroxyvitamin D levels were negatively correlated with HbA1c levels.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

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

September 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 9, 2016

Last Update Submit

September 14, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 25-hydroxyvitamin D levels

    The unit of measure was nmol/L. The detection limit of the device was \<10 nmol/L. A mean value of 5 nmol/L were taken for results reported as \<10nmol/L.

    Within 2 weeks from enrolment

  • HbA1c levels

    The unit of measure was percentage (using NGSP standarization).

    Within 2 weeks from enrolment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who attended specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.

You may qualify if:

  • eGFR 15-59 ml/min/1.73m2
  • age ≥ 18 years old
  • able to provide informed consent

You may not qualify if:

  • active infections
  • autoimmune diseases
  • malignancies
  • on immunosuppressive therapy
  • on vitamin D supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D DeficiencyDiabetes Mellitus

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Yong Muh Ng, MMed

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 20, 2016

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

A dataset of participants' clinical characteristics and biochemical tests result. The data was obtained directly from the participants and via Laboratory Information System. It is ready for submission.