title: Rationale and design of a randomized controlled trial of the effect of retinol and vitamin D supplementation on treatment in active pulmonary tuberculosis patients with diabetes.
abstract: BACKGROUND
  The association between pulmonary tuberculosis (PTB) and diabetes mellitus (DM) has been previously attracted much attention. Diabetes alters immunity to tuberculosis, leading to more frequent treatment failure in TB patients with DM. Moreover, TB and DM often coincide with micronutrients deficiencies, such as retinol and vitamin D, which are especially important to immunity of the body and may influence pancreas β-cell function. However, the effects of retinol and vitamin D supplementation in active TB patients with diabetes on treatment outcomes, immune and nutrition state are still uncertain. We are conducting a randomized controlled trial of vitamin A and/or D in active PTB patients with DM in a network of 4 TB treatment clinics to determine whether the supplementation could improve the outcome in the patients.
  
  
  METHODS
  This is a 2×2 factorial trial. We plan to enroll 400 active PTB patients with DM, and randomize them to VA (2000 IU daily retinol); VD (400 IU daily cholecalciferol); VAD (2000 IU daily retinol plus 400 IU cholecalciferol) or control (placebo) group. Our primary outcome measure is the efficacy of anti-tuberculosis treatment and ameliorating of glucose metabolism, and the secondary outcome measure being immune and nutrition status of the subjects. Of the first 37 subjects enrolled: 8 have been randomized to VA, 10 to VD, 9 to VAD and 10 to control. To date, the sample is 97.3% Han Chinese and 91.9% female. The average fasting plasma glucose level is 12.19 mmol/L.
  
  
  CONCLUSIONS
  This paper describes the design and rationale of a randomized clinical trial comparing VA and/or VD supplementation to active pulmonary TB patients with DM. Our trial will allow rigorous evaluation of the efficacy of the supplementation to active TB and DM therapy for improving clinical outcomes and immunological condition. This detailed description of trial methodology can serve as a template for the development of future treatment scheme for active TB patient with DM.
  
  
  BACKGROUND
  ChiCTR-TRC-12002546.
authors: The Institute of Human Nutrition, Medical College of Qingdao University, 38 Dengzhou Road, Qingdao 266021, China.
authors: Qiuzhen
authors: Q
authors: Wang
authors: Aiguo
authors: A
authors: Ma
authors: Ib Christian
authors: IC
authors: Bygbjerg
authors: Xiuxia
authors: X
authors: Han
authors: Yufeng
authors: Y
authors: Liu
authors: Shanliang
authors: S
authors: Zhao
authors: Jing
authors: J
authors: Cai
mesh_terms: D000328:Adult; D002681:China / Q000453:epidemiology; D002762:Cholecalciferol / Q000008:administration & dosage*; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism / Q000382:microbiology*; D019587:Dietary Supplements; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000453:epidemiology / Q000378:metabolism*; D014801:Vitamin A / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage
chemical_list: D014815:Vitamins; D014801:Vitamin A; D002762:Cholecalciferol