Clinical Trial: Novel Isotope Dilution Technique to Assess Vitamin A Status and Hypervitaminosis A

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional



Official Title: Validation of a Novel Isotope Dilution Technique to Assess Vitamin A Status in Infants and Children in Bangladesh and Assessment of Plausible Risk of Hypervitaminosis A Am

Brief Summary:

Background:

  1. Burden: Recently Bangladesh has introduced mandatory vitamin A (VA) fortification of refined edible oil while high dose VA supplementations for infants and children are still in place as part of national program. Thus preschool children are plausible at risk of hypervitaminosis A.
  2. Knowledge gap: Serum VA concentration is not an authenticate indicator of VA status, while existing deuterium- VA isotope dilution methods to determine whole body VA status require 3 weeks and not applicable for infants and children.
  3. Relevance: Our research group has recently developed a new simplified equation to measure VA pool size in 4-5 days, highly correlated with compartmental model-predicted value and estimate VA pool size in adults with high precision. However, it is not clear whether this new simplified equation also works in infants and children. In this proposed study, we validate the method in healthy infants and infants with inflammatory condition as well as in children with adequate and high dietary VA intake.

Hypothesis: (1) Whole-body VA status in infant and children can be estimated without accounting for fractional catabolic rate in the context of inflammatory condition or higher dietary VA intake (2) Fortification of commonly consumed food item with VA along with periodic high dose VA supplementation would increase the risk of hypervitaminosis A among preschool children in Bangladesh

Methods: Our study comprises two studies. "Study 01" will be undertaken in infants while "Study 02" for preschool children. At first we need to undertake one feasibility study to verify whether the oral dose of 400 μg 13C10 or 13C3- retinyl acetate (isoto