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

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ClinicalTrials.gov Identifier: NCT02169570
Recruitment Status : Unknown
Verified June 2014 by Kashif Shafique, Dow University of Health Sciences.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Kashif Shafique, Dow University of Health Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Pulmonary Tuberculosis Dietary Supplement: Vitamin D Dietary Supplement: Calcium Dietary Supplement: Placebo Vit D Dietary Supplement: Placebo Calcium Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis (EVIDENT Study): a Randomized, Double Blind, Controlled Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D
Vitamin D supplementation Anti Tuberculosis Treatment with 600,000 IU of (I/M) vitamin D3 for 3 doses at 0, 4 and 12 weeks and color and taste matched placebo for calcium for 3 months
Dietary Supplement: Vitamin D
Other Names:
  • Vitamin D3
  • cholecalciferol

Dietary Supplement: Placebo Calcium
Placebo Comparator: Placebo
Anti Tuberculosis Treatment with placebo color matched for vitamin D and color and taste matched placebo for calcium
Dietary Supplement: Placebo Vit D
Dietary Supplement: Placebo Calcium
Experimental: Vitamin D and Calcium
Vitamin D and Calcium supplementation Anti TuberculosisTreatment with 600,000 IU of (I/M) vitamin D3 for 3 doses at 0, 4 and 12 weeks with daily 1000 mg calcium carbonate for 3 months
Dietary Supplement: Vitamin D
Other Names:
  • Vitamin D3
  • cholecalciferol

Dietary Supplement: Calcium



Primary Outcome Measures :
  1. Change in Weight [ Time Frame: 0, 4, 8, 12, 16, 20 and 24 weeks and 6 months ]
    Weight will be measured by digital weighing machine.

  2. Change in TB score [ Time Frame: 0, 4, 8, 12, 16, 20 and 24 weeks, 6 months ]
    Clinical examination would be used to calculate it. It is a validated assessment tool developed to objectively measure change in the clinical status of TB patients. Its components include self-reported symptoms (cough, shortness of breath, night sweats, chest pain, haemoptysis), clinical signs (tachycardia, pallor, fever, auscultatory findings) body mass index (BMI) and mid-upper arm circumference (MUAC). The TB score so achieved could range from 0-13. TB scores would be divided in 3 severity classes; Severity Class I (TB score 0 to 5), Class II (TB score 6 - 7) and Class III (TB score ≥ 8).

  3. Change Acid Fast Bacilli (AFB) smear (Sputum) [ Time Frame: 0, 4, 8, 12, 16 and 24 weeks, 6 months ]
    Clearance of sputum

  4. Change in chest X-ray [ Time Frame: 0, 8, 16 and 24 weeks , 6 months ]
    Three separate methods of disease categorization would be used based on the classification of the National Tuberculosis and Respiratory Disease Association. This would include classification into 'minimally', 'moderately' and far advanced categories of radiographic infiltrates Secondly, cavity size ; No Cavity, Cavity size < 4 cm and ≥ 4 cm. Thirdly, the bilateral lung fields would be divided in to 3 zones (6 total) and disease extent would be recorded as 'Zone involvement' depending on active parenchymal and cavitary disease.


Secondary Outcome Measures :
  1. Change Heamoglobin A1c (HbA1c) [ Time Frame: 0, 8, 16 and 24 weeks, 6 months ]
    Blood test from Dow Diagnostic and Research Laboratory (DDRL). Blood sample will taken by phlebotomist for the HBA1c from the participants

  2. Change in Fasting Blood Test (FBS) [ Time Frame: 0, 8, 16 and 24 weeks, 6 months ]
    Blood test from Dow Diagnostic and Research Laboratory (DDRL). Blood sample will taken by phlebotomist for the FBS from the participants after 8-10 hours of fasting

  3. Change in Random Blood Sugar (RBS) [ Time Frame: 0, 8, 16 and 24 weeks, 6 months ]
    Blood test from Dow Diagnostic and Research Laboratory (DDRL). Blood sample will taken by phlebotomist for the RBS from the participants



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30 to 60 years
  • Patients having both TB and type 2 DM
  • Patients consenting to participate
  • No history of previous ATT
  • Plane to have ATT and DM treatment

Exclusion Criteria:

  • Age less than 30 years or greater than 60 years
  • Pregnant women
  • Patients having either TB or type 2 DM
  • Patients refuse to participate
  • Patients having extra-pulmonary TB or Multi-drug resistant MDR TB or relapse cases
  • Patients having hepatic or renal diseases or HIV infection
  • Patients having hypo- or hyper-parathyroidism
  • Patients on corticosteroids or immunosuppressive or thiazides diuretics or any other drugs known to interfere with vitamin D levels

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169570


Contacts
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Contact: Nadia - Shah, MAS +92 333 2385220 nadia.shah@live.com
Contact: Saadiyah Rao, MSc +92 3312068133 dr.saadrao@gamil.com

Locations
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Pakistan
School of Public Health, Dow university of Health Sciences Not yet recruiting
Karachi, Sindh, Pakistan
Contact: Nadia Shah, MAS         
Contact: Saadiyah Rao, MSc         
Principal Investigator: Kashif Shafique, PhD         
Sub-Investigator: Saadiyah Rao, MSc         
Sub-Investigator: Nadia Shah, MAS         
Sponsors and Collaborators
Dow University of Health Sciences
Investigators
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Principal Investigator: Kashif - Shafique, PhD School of Public Health, Dow University of Health Sciences, Karachi, Pakistan

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Responsible Party: Kashif Shafique, Assistant Professor/ Vice Dean SPH, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT02169570     History of Changes
Other Study ID Numbers: SPH-P02
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Kashif Shafique, Dow University of Health Sciences:
Type 2 Diabetes Mellitus
Pulmonary Tuberculosis
Vitamin D
Calcium

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Tuberculosis
Tuberculosis, Pulmonary
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents