GVAS
Niveles de Retinol Hepatico y óseo en cadáveres de Adolescentes y Adultos Guatemaltecos (Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults)
Sponsor study identifier
observational
150
2 countries
5
Study Start
October 24, 2019
Actual (reported)Primary Completion
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Guatemala has enforced mandatory fortification of sugar with vitamin A (VA) since June 1974 and has led to a highly successful reduction in VA deficiency and associated disease. However, Ribaya-Mercado et al. 2014, estimated the biological impact of sugar fortified with retinyl palmitate that there may be a risk of chronic excess intake of preformed VA associated with programs of mass fortification. A recent food consumption survey in two departments in Guatemala found the average daily sugar intake in children under the age of two who aren´t being breastfed is 30.3 g, which translates into a daily intake of 272 μg of retinol (almost the full estimated average requirement (EAR) for that age group). Since data from the second National Survey on Micronutrients suggest a risk of VA toxicity, it is important to determine the levels of hepatic VA directly in corpses of individuals, of all ages, who have died of non-metabolic causes. Due to this, the investigators propose to assess liver and bone VA levels in combination with gene expression, histopathology and biochemical analyses, to elicit indications of hypervitaminosis A in Guatemala.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2019
Actual (reported)March 23, 2020
Actual (reported)June 18, 2020
Actual (reported)July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Liver Vitamin A concentration
Liver Vitamin A concentration
Enrolment
Liver Gene Expression
Gene expression associated with Vitamin A
Enrolment
Liver Histology
Histological changes associated with Vitamin A
Enrolment
Bone Gene Expression
Gene expression associated with Vitamin A
Enrolment
Bone Vitamin A concentration
Enrolment
Individuals aged 10-19 years
Individuals aged 20-39 years
Individuals aged 40+ years
Guatemalan cadavers, from 2 hospitals in Guatemala City, aged \>10 years with a non-metabolic cause of death, within 24 hours of death
Hospital Roosevelt
Guatemala City, Zona 11, Guatemala
INCAP
Guatemala City, Zona 11, Guatemala
Pineda, O. (1998). Fortification of Sugar with Vitamin A. Food and Nutrition Bulletin, 19(2), 131-136.
Ribaya-Mercado JD, Solomons NW, Medrano Y, Bulux J, Dolnikowski GG, Russell RM, Wallace CB. Use of the deuterated-retinol-dilution technique to monitor the vitamin A status of Nicaraguan schoolchildren 1 y after initiation of the Nicaraguan national program of sugar fortification with vitamin A. Am J Clin Nutr. 2004 Nov;80(5):1291-8. doi: 10.1093/ajcn/80.5.1291.
Olsen K, Suri DJ, Davis C, Sheftel J, Nishimoto K, Yamaoka Y, Toya Y, Welham NV, Tanumihardjo SA. Serum retinyl esters are positively correlated with analyzed total liver vitamin A reserves collected from US adults at time of death. Am J Clin Nutr. 2018 Nov 1;108(5):997-1005. doi: 10.1093/ajcn/nqy190.
Liver Tissue Samples Bone Tissue Samples
Francisco Chew, MD
Institute of Nutrition of Central America and Panama
Erick Boy, MD, PhD
HarvestPlus
Georg Lietz, PhD
Newcastle University
First Submitted
March 23, 2020
First Posted
June 18, 2020
Study Start
October 24, 2019
Actual (reported)Primary Completion
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Correlation Between Vitamin A / E Levels and Preeclampsia
Contact the study team to confirm eligibility.
Hospital General San Juan de Dios
Guatemala City, Zona 1, Guatemala
Morgue del INACIF
Guatemala City, Zona 3, Guatemala
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom
Study Completion
July 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 18, 2020
Record last verified: 2020-02
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