Vitamin A Deficiency Clinical Trial
— GVASOfficial title:
Niveles de Retinol Hepatico y óseo en cadáveres de Adolescentes y Adultos Guatemaltecos (Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults)
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - Aged >10 years - Non-metabolic cause of death (e.g. accidents, trauma, or violence from firearms, stabbings, cranial and other trauma, asphyxiation etc.) - No longer than 24 hours since the time of death - Lived in Guatemala (exposure to fortified sugar) Exclusion Criteria: - Aged <10 years - Individuals with metabolic or nutritional conditions (diabetes, dyslipidemias, chronic alcoholism, etc.) - Longer than 24 hours since the time of death - Not Guatemalan resident (Tourist, visitor etc.) |
Country | Name | City | State |
---|---|---|---|
Guatemala | Hospital General San Juan de Dios | Guatemala City | |
Guatemala | Hospital Roosevelt | Guatemala City | |
Guatemala | INCAP | Guatemala City | |
Guatemala | Morgue del INACIF | Guatemala City | |
United Kingdom | Newcastle University | Newcastle Upon Tyne | Tyne And Wear |
Lead Sponsor | Collaborator |
---|---|
Newcastle University | Bill and Melinda Gates Foundation, HarvestPlus, INACIF, Institute of Nutrition of Central America and Panama |
Guatemala, United Kingdom,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver Vitamin A concentration | Liver Vitamin A concentration | Enrolment | |
Primary | Liver Gene Expression | Gene expression associated with Vitamin A | Enrolment | |
Primary | Liver Histology | Histological changes associated with Vitamin A | Enrolment | |
Primary | Bone Gene Expression | Gene expression associated with Vitamin A | Enrolment | |
Secondary | Bone Vitamin A concentration | Bone Vitamin A concentration | Enrolment |
Status | Clinical Trial | Phase | |
---|---|---|---|
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