Effect of Supplementary Vitamin D in Patients With Diabetes Mellitus and Pulmonary Tuberculosis (EVIDENT Study): a Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 435
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
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.
详细描述
Pakistan is going through an epidemiological transition that subjects it to a dual burden of communicable and chronic diseases. According to WHO, Pakistan ranks seventh in diabetes prevalence and fifth amongst high TB burden countries. Pakistan faces challenges in controlling both these diseases with combine prevalence of 16%. This co-occurrence of DM and TB represents a big health risk in our population, as diabetes effects susceptibility to TB which makes more frequent treatment failure which could result in more community acquired TB infection. On the other hand, TB can worsen glycemic control in patients with diabetes. Moreover, overlapping of various drugs used in treatment might affect the glycemic control and pharmacokinetics of anti-TB treatment, resulting in the management of TB patients with DM more complex. Additionally, both DM and TB often coexist with micronutrients deficiencies like vitamin D and calcium. A vital role of vitamin D in immunity, insulin resistance and respiratory health has been suggested. Vitamin D and calcium deficiencies might adversely affect glycemic control, while combined supplementation with both of these micronutrients might be helpful in improving glucose metabolism which in turn will improve the treatment outcome for both these diseases. There is a suggestion that the combined supplementation with vitamin D and calcium might be beneficial in improving the glucose metabolism but the current knowledge is only limited to one randomized control trial in this co-morbid group carried out in India. Even in that trial independent effect of Vitamin D remain unknown as they used a combination therapy of calcium and vitamin D. Furthermore, that trial did not include radiological changes occurred during the follow-up period so that remains a major limitation. Therefore, this study will assess the role of supplementation with vitamin D and calcium in recovery (positive radiological changes, weight gain, sputum conversion, and glycemic control) of pulmonary TB patients with type 2 DM.The goal of our trial is to better understand the role of micro nutrients supplementation in among patients who have active TB and type 2 DM in their disease prognosis.
The objectives are as follows:
- To determine the whether the 3 doses of vitamin D 600,000 IU at intervals of 4 weeks alone or in combination with calcium 1000mg for 3 months given with standard TB and type 2 DM treatment makes more rapid improvement in clinical indicators that are weight and TB score among 30 to 60 years old patients of active pulmonary TB with type 2 DM attending Ojha Institute of Chest Disease (OICD).
- To determine the whether the mentioned doses of vitamin D and calcium with standard TB and type 2 DM treatments expedites radiological resolution and sputum conversion.
- To determine whether the mentioned doses of vitamin D and calcium with standard TB and type 2 DM treatments is efficacious on glycemic control among these patients.
- To guide future clinical treatment for such patients.
Methods:
Study Design and Setting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Weight
时间窗: 0, 4, 8, 12, 16, 20 and 24 weeks and 6 months
Weight will be measured by digital weighing machine.
Change in TB score
时间窗: 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).
Change Acid Fast Bacilli (AFB) smear (Sputum)
时间窗: 0, 4, 8, 12, 16 and 24 weeks, 6 months
Clearance of sputum
Change in chest X-ray
时间窗: 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.
次要结局
- 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)
研究者
Kashif Shafique
Assistant Professor/ Vice Dean SPH
Dow University of Health Sciences