Reference Physiological Ranges for Serum Biochemical Parameters among Healthy Cameroonians to Support HIV Vaccine and Related Clinical Trials

Abstract

Background: A valid scientific evaluation of the efficacy of HIV vaccines or antiretroviral drugs includes measurement of changes in physiological parameters of subjects from known established baseline reference ranges. This study was designed to establish reference ranges for biochemical parameters among healthy adult Cameroonians to support planned HIV Vaccine clinical trials and scaling up of ARV drugs among AIDS patients.
Methods: After informed consent, blood and urine samples were collected from a total of 576 adult Cameroonians and analyzed for the presence of underlying pathologies that may affect biochemical parameters. Samples from 501 of them were found eligible for the determination of reference biochemical parameters. After complete assay, the data were subjected to both parametric and non parametric statistics for analyses with 2.5 and 97.5 percentiles considered as the lower and upper limits of reference ranges.
Results: There were 331(66.1%) males and 170(33.9) females, with 359(71.7%) and 142(28.3) of them residing in the urban and rural areas respectively. Statistically significant differences (P<0.05) were observed in the following biochemical parameters between urban and rural participants: AST, ALT, alkaline phosphatase, creatinine, total protein, albumin, triglyceride, total cholesterol, and the bilirubins. When the data were regrouped into sex, there were statistically significant differences (P<0.05) in the following parameters between males and females: AST, ALT, creatinine, albumin, triglyceride, total cholesterol, and direct bilirubin.
Conclusion: The present study shows that sex and geographic location have significant impact on reference physiological biochemical parameters of healthy, adult Cameroonians; hence this should be taken into consideration when monitoring participants either during HIV Vaccine clinical trials or on antiretroviral (ARV) drugs treatment.

Key Words: Normal Biochemical Ranges, Health Adult Cameroonians.