Examining the effectiveness of consuming flour made from agronomically biofortified wheat (Zincol-2016/NR-421) for improving Zn status in women in a low-resource setting in Pakistan: study protocol for a randomised, double-blind, controlled cross-over trial (BiZiFED).

INTRODUCTION: Dietary zinc (Zn) deficiency is a global problem, particularly in low-income and middle-income countries where access to rich, animal-source foods of Zn is limited due to poverty. In Pakistan, Zn deficiency affects over 40% of the adult female population, resulting in suboptimal immune status and increased likelihood of complications during pregnancy. METHODS AND ANALYSIS: We are conducting a double-blind, randomised controlled feeding study with cross-over design in a low-resource setting in Pakistan. Households were provided with flour milled from genetically and agronomically biofortified grain (Zincol-2016/NR-421) or control grain (Galaxy-2013). Fifty households were recruited. Each household included a woman aged 16-49 years who is neither pregnant nor breastfeeding, and not currently consuming nutritional supplements. These women were the primary study participants. All households were provided with control flour for an initial 2-week baseline period, followed by an 8-week intervention period where 25 households receive biofortified flour (group A) and 25 households receive control flour (group B). After this 8-week period, groups A and B crossed over, receiving control and biofortified flour respectively for 8 weeks. Tissue (blood, hair and nails) have been collected from the women at five time points: baseline, middle and end of period 1, and middle and end of period 2. ETHICS AND DISSEMINATION: Ethical approval was granted from the lead university (reference no. STEMH 697 FR) and the collaborating institution in Pakistan. The final study methods (including any modifications) will be published in peer-reviewed journals, alongside the study outcomes on completion of the data analysis. In addition, findings will be disseminated to the scientific community via conference presentations and abstracts and communicated to the study participants through the village elders at an appropriate community forum. REGISTRATION DETAILS: The trial has been registered with the ISRCTN registry, study ID ISRCTN83678069.

Risk factors for multi-drug resistant tuberculosis in patients at tertiary care hospital, Peshawar.

OBJECTIVE: To determine the frequency of common risk factors for multi-drug resistant tuberculosis in patients presented at a tertiary care hospital, Peshawar. STUDY DESIGN: Cross-sectional, observational study. PLACE AND DURATION OF STUDY: Pulmonology Department, Khyber Teaching Hospital, Peshawar, from December 2006 to October 2007. METHODOLOGY: Patients with positive AFB culture and sensitivity results and found resistant to both rifampicin and isoniazid with or with resistance to other first line anti-tuberculosis drugs, were recruited from both Pulmonology Ward and Outpatient Department (OPD). Informed verbal consent was taken and a questionnaire administered to all participants of the study. Information regarding demographics, education status, occupation, monthly household income, AFB C/S, details of past history of tuberculosis and family history of TB or Multi-Drug Resistant (MDR-TB) was recorded. Data was analyzed on SPSS version 11. RESULTS: A total of 30 patients of MDR-TB were interviewed. Male (n=17) and female (n=13) ratio was 1.3:1. Mean age was 34.2+/-15.3 years. Ninety-two percent female and 52.9% male were uneducated. In 56.7%, monthly income was less than 5,000 rupees and in 40% between 5,000-10,000 rupees. All patients had previous history of Antituberculous Treatment (ATT), in which 20% had undertaken ATT course once, 53.3% twice and 26.7% thrice in the past. In the study group, 13 (43.3%) patients had not completed their first ATT course and 11 of them were receiving ATT from a general practitioner (GP) at that time. Seven (23.3%) patients had family history of TB but no one had documented MDR-TB in the family. Resistance to RH was present in all patients; moreover, 56.7% had resistance to RHEZ+S. CONCLUSION: The most common factors in the study group were previous history of tuberculosis, repeated courses of ATT, prescribed by different clinicians and unsupervised treatment by a GP during the initial course of ATT.