Chemoprevention of oral leukoplakia with vitamin A and beta carotene: an assessment.

We conducted a double-blind placebo-controlled trial to evaluate the chemopreventive potential of either vitamin A alone or beta carotene alone in subjects with oral leukoplakia in Kerala, India. We randomised 160 fishermen and women with oral precancerous lesions to receive oral vitamin A (retinyl acetate 300,000 IU/week x 12 months, n = 50), or beta carotene (360 mg/week x 12 months, n = 55), or placebo (n = 55). Blood, saliva and urine samples were collected at baseline and at exit to study serum micronutrients and mutagenicity assays. Biopsies of the mucosal lesions at entry were performed for histopathological exclusion of malignancy. The subjects were examined once every 2 months to establish clinical response of lesions and toxicity, if any. The results are based on 43 complaint subjects on placebo, 42 on vitamin A and 46 on beta carotene. The complete regression rates were: 10% in the placebo arm, 52% with vitamin A and 33% with beta carotene (P < 0.0001). Homogeneous leukoplakias and smaller lesions responded better than non-homogeneous and larger lesions. No major toxicities were observed. Half of the responders with beta carotene and two thirds with vitamin A relapsed after stopping supplementation. Serum beta carotene concentration increased substantially with beta carotene administration while with vitamin A supplementation there was no change in serum retinol levels. In the vitamin A treated group there was a significant decrease in serum alpha tocopherol. Vitamin A administration resulted in a significant remission of oral leukoplakia without any side effects of prolonged vitamin A supplementation. The results of this study, as well as those from previous studies, appear to provide strong supporting evidence to justify long term trials with vitamin A in subjects with high-risk leukoplakias with oral cancer as an endpoint.

Studies on some trace and minor elements in blood. A survey of the Kalpakkam (India) population. Part I: Standardization of analytical methods using ICP-MS and AAS.

Blood is one of the widely used specimens for biological trace element research because of its biological significance and ease of sampling. We have conducted a study of the blood of the Kalpakkam township population for trace and minor elements. For this purpose, analytical methods have been developed and standardized in our laboratory for the elemental analysis of blood plasma and red cells. Inductively coupled plasma-mass spectrometry (ICP-MS), a relatively new technique, has been applied for the analysis of trace elements. Details regarding spectral interference and matrix interference encountered in the analysis of blood and the methods of correcting them have been discussed. Flame atomic absorption spectrometry (AAS)/atomic emission spectrometry (AES) has been applied for the determination of minor elements. Precision and accuracy of these methods have also been discussed.

Studies on some trace and minor elements in blood. A survey of the Kalpakkam (India) population. Part III: Studies on dietary intake and its correlation to blood levels.

In our studies on elemental levels in blood of the Kalpakkam population, it was found that the reference values for many elements were normal, but some deficiency with respect to Se was noticed. As a followup study, the dietary ingredients of the local population were analyzed for trace and minor elements to assess the dietary intake of these elements. Details of the analytical methods developed using the technique of inductively coupled plasma-mass spectrometry (ICP-MS) and atomic absorption spectrometry (AAS) have been described. The dietary intake of many of these trace and minor elements were found to be quite adequate according to the recommended dietary allowance (RDA) levels prescribed, except for Se and Zn. The dietary intake of Se was found to be in the range 20-50 micrograms/d (as opposed to the RDA of 50-200 micrograms/d), whereas the intake of Zn was found to be in the range 8-10 mg/d (as opposed to the RDA of 15 mg/d). Although the deficiency of Se intake was reflected in the blood, that of Zn was not, probably owing to the high level of homeostasis for this element. Fish and egg were found to be rich sources of Se, followed by cereals and pulses, which were found to be the major sources of Zn.

Studies on some trace and minor elements in blood. A survey of the Kalpakkam (India) population. Part II: Reference values for plasma and red cell, and correlation with coronary risk index.

Since data on the trace element levels in Indian population are lacking, we chose to conduct a survey of the Kalpakkam township population. People in the age group 40-55 were included in this study. Reference values for trace and minor elements of the blood of the Kalpakkam population were arrived at by carrying out the analysis of plasma and red cells of healthy subjects of the Kalpakkam population. Although the "reference values" for many elements were found to be normal and comparable to values available in the literature, slight deficiency with respect to Se was noticed. Subjects with high coronary risk index were also included in the study to assess the possible correlation of elemental and lipid profile. A study of box plots showed that the elements Se, Mg, Na, K, and Fe show significant differences between "high risk" coronary risk index (CRI > 5) and "no risk" (CRI < 4.5). In the plasma, the levels of Mg, Na, and K were found to be less in the high-risk group. In red cells, the amount of Se, Fe, and K were found to be significantly less in the "high-risk" group as compared to the "no-risk" group.