CTRI requirement of prospective trial registration: Not always consistent

In a clinical trial registry, one determines whether a trial is registered prospectively or retrospectively by comparing the date of registration with the date on which enrollment started. However, in Clinical Trials Registry – India (CTRI), in addition, the top of each record is labelled with the phrase “Trial Registered Prospectively” or “Trial Registered Retrospectively”. In examining CTRI records, we have found that (a) although retrospective registration has been disallowed from April 1, 2018, some trials were registered retrospectively; (b) in some cases, enrollment started after registration, even though they were labelled “Trial Registered Retrospectively”, which is misleading; and (c) in some cases, the date of first enrollment was modified, changing a retrospective registration to a prospective one, although the label “Trial Registered Retrospectively” persisted. This, too, is misleading. The CTRI administration should take suitable steps to prevent late registration and mislabelling of trials regarding their registration status.

Elimination of iodine deficiency disorders--current status in Purba Medinipur district of West Bengal, India.

BACKGROUND AND OBJECTIVES: Towards sustainable elimination of iodine deficiency disorders (IDD), the existing programme needs to be monitored through recommended methods and indicators. Thus, we conducted the study to assess the current status of IDD in Purba Medinipur district, West Bengal. METHODS: It was a community based cross-sectional study; undertaken from October 2006-April 2007. 2400 school children, aged 8-10 years were selected by '30 cluster' sampling technique. Indicators recommended by the WHO/UNICEF/ICCIDD were used. Subjects were clinically examined by standard palpation technique for goitre, urinary iodine excretion was estimated by wet digestion method and salt samples were tested by spot iodine testing kit. RESULTS: The total goitre rate (TGR) was 19.7% (95% CI = 18.1-21.3 %) with grade I and grade II (visible goitre) being 16.7% and 3% respectively. Goitre prevalence did not differ by age but significant difference was observed in respect of sex. Median urinary iodine excretion level was 11.5 mcg/dL and none had value less than 5 mcg/dL. Only 50.4% of the salt samples tested were adequately iodised (> or = 15 ppm). CONCLUSION: The district is in a phase of transition from iodine deficiency to iodine sufficiency as evident from the high goitre prevalence (19.7%) and median urinary iodine excretion (11.5 mcg/dL) within optimum limit. But, salt iodisation level far below the recommended goal highlights the need for intensified efforts towards successful transition.

Iodine deficiency disorders among school children of Dakshin Dinajpur District, West Bengal.

Iodine deficiency disorders (IDD) are major public health problems in India, including West Bengal. Existing programme to control IDD needs to be continuously monitored through recommended methods and indicators. Thus we undertook the study to assess the prevalence of goiter, status of urinary iodine excretion (UIE) level and to estimate iodine content of salts at the household level in Dakshin Dinajpur district, West Bengal. We conducted a community-based, cross-sectional study in 2004; among 2250 school children, aged 8-10 years. The '30 cluster' sampling methodology and indicators for assessment of IDD, as recommended by the joint WHO/UNICEF/ICCIDD consultation, were used for the study. Goitre was assessed by standard palpation technique, UIE was analyzed by wet digestion method and salt samples were tested by spot iodine testing kit. Of the 2250 children, 419 (18.6%) had goitre (95% CI = 17.0 - 20.2%). Total goitre rate (TGR) was not significantly different in respect of gender, age and religion. Visible goitre rate was 2.5%. Median urinary iodine excretion level was 16 mcg/dL (normal: > or = 10 mcg/dl.) and 16.5% children had value less than 5 mcg/dL. Only 67.4% of the salt samples tested had adequate iodine content of > or = 15 ppm, with significant difference between Hindus and Muslims (chi2 = 12.68, d.f. = 1, p < 0.01). TGR of 18.6% indicate the district is still endemic for IDD, but median urinary iodine within normal range reflects no current iodine deficiency. The district is in the transition phase from iodine-deficient to iodine-sufficient. Measures are to be sustained for successful transition towards elimination.

Evaluation of vitamin A status during pregnancy.

Adequate maternal vitamin A nutrition is essential for successful pregnancy outcome and estimation of serum retinol among pregnant women enables a precise and objective assessment of vitamin A status, during pregnancy, even in subclinical state. In order to evaluate vitamin A status during pregnancy, and its relationship with personal and pregnancy related variables of the mother, 300 antenatal clinic attenders were interviewed at RG Kar Medical College and Hospital, Calcutta and tested for serum retinol, using Carr-Price test. Serum retinol values less than 30 microg/dl and 20 microg/dl, in this study, were considered as poor and severe vitamin A deficiency respectively. According to this 14.7% and 4% pregnant women were found to be suffering from poor and severe vitamin A deficiency respectively. Clinical signs of vitamin A deficiency (eg, nightblindness) were reported only among 60% cases of the deficient population. The problems of vitamin A deficiency were associated with low literacy and poor nutritional status of the mother, advanced gestational age of current pregnancy,increased number of pregnancies, shorter interval between births and poor dietary intake of vitamin A rich foods during pregnancy. The study thus raises the question of supplementation of vitamin A, during pregnancy, in Indian context where habitual diets are either inadequate or deficient in vitamin A.