Liver and Bone Retinol Levels in Guatemalan Adolescents and Adults

NCT04438200 | Unknown

• 1 other identifier: VDACS-MF-0109-2019
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Vitamin A Deficiency; Vitamin A Toxicity; Hypervitaminosis A

Keywords

Retinol; Hypervitaminosis A; Hepatic Vitamin A; Guatemala

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Bone Vitamin A concentration

  Enrolment

Study Arms (3)

Adolescents

Individuals aged 10-19 years

Young Adults

Individuals aged 20-39 years

Elderly Adults

Individuals aged 40+ years

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Guatemalan cadavers, from 2 hospitals in Guatemala City, aged \>10 years with a non-metabolic cause of death, within 24 hours of death

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Newcastle University: lead
• Bill and Melinda Gates Foundation: collaborator
• HarvestPlus: collaborator
• Institute of Nutrition of Central America and Panama: collaborator
• INACIF: collaborator

Study Sites (5)

Hospital Roosevelt

Guatemala City, Zona 11, Guatemala

RECRUITING

INCAP

Guatemala City, Zona 11, Guatemala

RECRUITING

Hospital General San Juan de Dios

Guatemala City, Zona 1, Guatemala

RECRUITING

Morgue del INACIF

Guatemala City, Zona 3, Guatemala

RECRUITING

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (3)

• Pineda, O. (1998). Fortification of Sugar with Vitamin A. Food and Nutrition Bulletin, 19(2), 131-136.

  BACKGROUND

• 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.

  PMID: 15531678 BACKGROUND

• 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.

  PMID: 30475970 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Liver Tissue Samples Bone Tissue Samples

MeSH Terms

Conditions

Vitamin A Deficiency; Hypervitaminosis A

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Francisco Chew, MD

  Institute of Nutrition of Central America and Panama

  PRINCIPAL INVESTIGATOR

• Erick Boy, MD, PhD

  HarvestPlus

  PRINCIPAL INVESTIGATOR

• Georg Lietz, PhD

  Newcastle University

  STUDY DIRECTOR

Central Study Contacts

Georg Lietz, PhD

CONTACT

00441912086893; georg.lietz@newcastle.ac.uk

Kieran Finney, BSc (Hons).

CONTACT

00441912081403; kieran.finney@newcastle.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: June 18, 2020
• Study Start: October 24, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GU (4); GB (1)