drugset / Trial / NCT03801161

Influence of Inflammation on Micronutrient Status Assessment

NCT03801161

RandomizedParallel-groupOpen-labelDiagnostic

Summary

Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. A total of 40 infants (9-18 mo of age) will participate in this study. Investigators will use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). The investigators will also use two different stable isotopic retinols for the assessment of total body vitamin A stores. Baseline blood samples (5 mL) will be obtained from all infants and then randomly selected 30 infants will receive PENTA vaccines, while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP and on the same day, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP\> 5mg/L) in the vaccine group and also from infants in the control group. Thus estimated plasma micronutrients and vitamin A stores before and after inflammation will calculate the effects of inflammation on the interpretation of micronutrient deficiencies based on biochemical indicator assessment.

Timeline

Start
2018-06-01
Primary completion
2019-03-31
Completion
2019-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pentavalent vaccine Vaccine

Indications

No indication recorded.