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Effect of Consuming Vitamin A-fortified Sugar on Serum Retinol Levels in Children
Sponsor: Universidad del Valle, Colombia
Summary
The increase in vitamin A deficiency (\<20 mcg/dL) among children under five in Colombia (2010-2015) is a public health problem (27.3%). The objective of this randomized, controlled, double-blind clinical trial was to determine whether daily consumption of retinol-fortified sugar (23.5 mcg ER/day) was effective in treating this deficiency in children; furthermore, to evaluate whether daily sugar consumption (13 g/day) increased excess weight (P/T: overweight and obesity) in them. The main questions were: * Does daily consumption of retinol-fortified sugar (23.5 mcg ER/g) significantly increase serum retinol levels in children in the intervention group during the study? * What is the increase in weight-for-height among study participants at the end of the intervention following daily consumption of sugar in various meals throughout the day? The researchers compared daily consumption of retinol-fortified sugar over three months with daily consumption of regular sugar or a placebo to determine whether the fortified sugar was effective in increasing serum retinol levels in children in the intervention group and, furthermore, whether the increase in weight-for-height among participants at the end of the study showed no statistically significant differences compared to baseline. Participants were required to: * Children undergo antiparasitic treatment at each school with 400 mg of albendazole before starting the sugar intervention, in the presence of a nutritionist from the team. * The nutritionist be able to assess the children's anthropometric indicators at the beginning and end of the study to evaluate changes in the presence of undernutrition or excess weight (overweight and obesity). * Caregivers must allow the collection of two 5-ml blood samples: the first to assess baseline serum levels of retinol and CRP before the intervention; and the second and final sample at the end of the intervention to measure the levels of retinol and CRP achieved during the study through the consumption of retinol-fortified sugar. * Caregivers would provide baseline information on the consumption of food groups (at baseline: semiquantitative frequency of consumption; and at baseline and at the end of the study: 24-hour dietary recalls). In addition, they would provide information at three different time points on the semiquantitative consumption of supplements and foods that are sources of vitamin A and carotenoids. * Caregivers and teachers will provide the nutritionist with information at baseline, during the intervention, and at the end of the study regarding the presence of infectious diseases, clinical signs of infection and their duration, as well as the occurrence of adverse events among participants who consumed fortified sugar (13 g/day: 23.5 mcg ER/g).
Official title: Randomized Controlled Clinical Trial in Children to Evaluate the Effect of Consuming Retinol-fortified Sugar
Key Details
Gender
All
Age Range
3 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-07-25
Completion Date
2025-12-16
Last Updated
2026-10-06
Healthy Volunteers
Yes
Interventions
white sugar fortified with retinol
INTERVENTION: 49 participants who consumed sugar daily at home and in the cafeteria of the school where they were enrolled, of both sexes, from all ethnic groups, aged 3 to 6 years, residing in vulnerable areas of Cali, enrolled in 4 randomly selected schools, recipients of assistance from the Cali Food Bank, dewormed and without clinical signs of vitamin A deficiency, free of infections or chronic diseases, with baseline measurements of nutritional status (weight, height, and arm circumference), health status, serum retinol-PCR, and dietary intake, who consumed 13 g/day of retinol-fortified sugar (23.5 mcg ER/g) as a culinary ingredient in various daily food preparations during the three-month treatment period.
refined white sugar for culinary use
40 participants who consumed sugar daily at home and in the cafeteria of the educational institution where they were enrolled; of both sexes; from all ethnic groups; between 3 and 6 years of age; residing in vulnerable areas of Cali; enrolled in 3 randomly selected schools; recipients of assistance from the Cali Food Bank; who had been treated for parasitic infections and showed no clinical signs of vitamin A deficiency, no infections or chronic diseases, and for whom baseline measurements of nutritional status (weight, height, and arm circumference), health, serum retinol-CRP, and food intake had been taken.
Locations (1)
Banco de Alimentos de Cali
Cali, Valle del Cauca Department, Colombia