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

NCT02169570 | Unknown Phase 4 DMC

• 1 other identifier: SPH-P02
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Pulmonary Tuberculosis

Keywords

Type 2 Diabetes Mellitus; Pulmonary Tuberculosis; Vitamin D; Calcium

Outcome Measures

Primary Outcomes (4)

• Change in Weight

  Weight will be measured by digital weighing machine.

  0, 4, 8, 12, 16, 20 and 24 weeks and 6 months

• Change in TB score

  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).

  0, 4, 8, 12, 16, 20 and 24 weeks, 6 months

• Change Acid Fast Bacilli (AFB) smear (Sputum)

  Clearance of sputum

  0, 4, 8, 12, 16 and 24 weeks, 6 months

• Change in chest X-ray

  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.

  0, 8, 16 and 24 weeks , 6 months

Secondary Outcomes (3)

• Change Heamoglobin A1c (HbA1c)

  0, 8, 16 and 24 weeks, 6 months

• Change in Fasting Blood Test (FBS)

  0, 8, 16 and 24 weeks, 6 months

• Change in Random Blood Sugar (RBS)

  0, 8, 16 and 24 weeks, 6 months

Study Arms (3)

Vitamin D

ACTIVE COMPARATOR

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; Dietary Supplement: Placebo Calcium

Placebo

PLACEBO COMPARATOR

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

Vitamin D and Calcium

EXPERIMENTAL

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; Dietary Supplement: Calcium

Interventions

Vitamin D DIETARY_SUPPLEMENT

Also known as: Vitamin D3, cholecalciferol

Vitamin D; Vitamin D and Calcium

Calcium DIETARY_SUPPLEMENT

Vitamin D and Calcium

Placebo Vit D DIETARY_SUPPLEMENT

Placebo

Placebo Calcium DIETARY_SUPPLEMENT

Placebo; Vitamin D

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

School of Public Health, Dow university of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Tuberculosis, Pulmonary

Interventions

Vitamin D; Cholecalciferol; Calcium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Kashif - Shafique, PhD

  School of Public Health, Dow University of Health Sciences, Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia - Shah, MAS

CONTACT

+92 333 2385220; nadia.shah@live.com

Saadiyah Rao, MSc

CONTACT

+92 3312068133; dr.saadrao@gamil.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/ Vice Dean SPH

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 23, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

PA (1)