Vitamin D DeficiencyNCT02906319
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
An observational study of Vitamin D Deficiency and Diabetes Mellitus, run by Ng Yong Muh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Diabetes Mellitus
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who attended specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Who may be able to join
- eGFR 15-59 ml/min/1.73m2
- age ≥ 18 years old
- able to provide informed consent
Who cannot join
- active infections
- autoimmune diseases
- malignancies
- on immunosuppressive therapy
- on vitamin D supplements
About this study
Official title: Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease
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.
Read the detailed description
This was a cross sectional study using consecutive sampling methodology for participant recruitment. It was carried out at the specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Serum 25(OH)D levels were determined by using direct chemiluminesent immunoassay (ADVIA Centaur XP; Siemens Healthcare Diagnostics, Tarrytown, New York, USA). Serum HbA1c levels were determined using high-pressure liquid chromatography (Variant™ II Turbo; Bio-Rad, Hercules, California, USA).
Data collected will be analyzed using Statistical Package for Social Sciences SPSS version 23.0 for Windows, version 23.0 (IBM Corp., Armonk, New York, USA).
- Conditions
- Vitamin D Deficiency, Diabetes Mellitus
- Medical subject headings
- Vitamin D Deficiency, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 weeks from enrolment
HbA1c levels
The unit of measure was percentage (using NGSP standarization).
Measured: Within 2 weeks from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ng Yong Muh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya, Malaysian Society of Nephrology
- Responsible party
- Sponsor-investigator, Ng Yong Muh, University of Malaya
- Investigators
- Yong Muh Ng, MMed, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906319
- Sponsor's protocol ID
- 201412-878
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum 25-hydroxyvitamin D Levels and Glycated Haemoglobin in Diabetic Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02906319
- Acronym / sponsor ID
- 201412-878
- Conditions
- Vitamin D Deficiency, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ng Yong MuhUniversity, hospital or other
- Collaborators
- University of Malaya, Malaysian Society of Nephrology
- Study start
- Sep 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a cross sectional study using consecutive sampling methodology for participant recruitment. It was carried out at the specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Serum 25(OH)D levels were determined by using direct chemiluminesent immunoassay (ADVIA Centaur XP; Siemens Healthcare Diagnostics, Tarrytown, New York, USA). Serum HbA1c levels were determined using high-pressure liquid chromatography (Variant™ II Turbo; Bio-Rad, Hercules, California, USA).
Data collected will be analyzed using Statistical Package for Social Sciences SPSS version 23.0 for Windows, version 23.0 (IBM Corp., Armonk, New York, USA).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who attended specialized diabetic, renal, and general outpatient clinics in the University of Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia.
Key inclusion criteria (3 listed)
- eGFR 15-59 ml/min/1.73m2
- age ≥ 18 years old
- able to provide informed consent
Key exclusion criteria (5 listed)
- active infections
- autoimmune diseases
- malignancies
- on immunosuppressive therapy
- on vitamin D supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
25-hydroxyvitamin D levels
Time frame: Within 2 weeks from enrolment
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.
HbA1c levels
Time frame: Within 2 weeks from enrolment
The unit of measure was percentage (using NGSP standarization).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Muh Ng, MMed principal investigator
University of Malaya
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Diabetes Mellitus, run by Ng Yong Muh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-hydroxyvitamin D levels (time frame: Within 2 weeks from enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.