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Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis

NCT02169570 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2014-06-23

No results posted yet for this study

Summary

Pakistan ranks fifth amongst high tuberculosis-(TB) burden countries, where TB persists as a major cause of misery and death. The Diabetes Mellitus-(DM) is also on rise in Pakistan and people suffering from DM are more prone to catch TB as compared to healthy individuals. This concurrence of two outbreaks may further increase the frequency of TB in Pakistan. The TB DM co-occurrence results in various clinical issues as TB in DM patient increases blood glucose, making DM more difficult to treat, while DM raises the risk of treatment failure, relapse and death among TB patients. In addition, both DM and TB usually coexist with micronutrients deficiencies like vitamin D, which has a vital role in immunity, insulin functioning and respiratory health. It has been suggested that the combined supplementation with vitamin D and calcium might be beneficial in improving the glucose metabolism but the current knowledge is very limited. In a resource restrained country with double burden of infectious and non-infectious diseases, an integrated approach with modification of treatment options may benefit in management of these outbreaks.

Therefore, this study aims whether vitamin D and calcium supplementation could influence the recovery in patients with TB of lung and DM.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D

DIETARY_SUPPLEMENT

Calcium

DIETARY_SUPPLEMENT

Placebo Vit D

DIETARY_SUPPLEMENT

Placebo Calcium

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Principal Investigators

  • Kashif - Shafique, PhD · School of Public Health, Dow University of Health Sciences, Karachi, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169570 on ClinicalTrials.gov