Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers

NCT03345147 | Completed

• 1 other identifier: CIE-REV 061/2016
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin A intakes (250-600 ug per day).

Conditions

Vitamin A Status

Keywords

Vitamin A; Isotopic dilution; dietary assessment

Outcome Measures

Primary Outcomes (2)

• Total Vitamin A stores among 3-5 years-old children, in micromoles

  Estimated using Carbon 13 (13C) 13C-retinol dilution method, by the ratio of Labelled (stable isotope) versus no labelled Vitamin A in plasma 4 days after dose of labelled VA is given.

  28-day study period

• Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug)

  Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire

  28-day study period

Secondary Outcomes (9)

• Plasma retinol among 3-5 years-old children

  28-day study period

• Plasma retinol binding protein among 3-5 years-old children

  28-day study period

• Plasma Transthyretin among 3-5 years-old children

  28-day study period

• Bone Health markers among 3-5 years-old children

  28-day study period

• Liver function markers among 3-5 years-old children

  28-day study period

Other Outcomes (5)

• Hemoglobin concentration in children

  At recruitment

• Children weight and length

  At recruitment

• Systemic inflammation in children

  At recruitment

Study Arms (2)

Normal Vitamin A intake

Normal Vitamin A intake will be assessed by a questionnaire directed to the consumption of food items with high VA content on the 7 days prior to the questionnaire. The daily consumption will be assessed on average. A child is assigned to Normal Vit. A consumption if daily Vit. A is between 250 and 600 micrograms per day.

Other: Normal Vitamin A intake

High Vitamin A intake

High Vitamin A intake will be assessed by a questionnaire directed to the consumption of food items with high VA content on the 7 days prior to the questionnaire. The daily consumption will be assessed on average. A child is assigned to High Vit. A consumption if daily Vit. A is above 900 micrograms per day.

Other: High Vitamin A intake

Interventions

High Vitamin A intake OTHER

Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).

High Vitamin A intake

Normal Vitamin A intake OTHER

Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).

Normal Vitamin A intake

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and Women from Guatemala peri-urban areas or areas where High Vitamin A foods intake is reported. Convenience sampling according to the availability (time to participate in the study) of the participant, and acceptance of Blood sampling and Dietary assessments

You may qualify if:

• Children 3-5 years old and their mothers
• Child VA intake must be above 250 micrograms/day
• Children must be apparently healthy, Hemoglobin\>9 g/dL at recruitment point, C-reactive protein\<5 mg/L. For Women, Hemoglobin\>10 g/dL, C-reactive protein\<5 mg/L

You may not qualify if:

• °Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases

Sponsors & Collaborators

• Institute of Nutrition of Central America and Panama: lead
• Newcastle University: collaborator
• Bill and Melinda Gates Foundation: collaborator
• International Atomic Energy Agency: collaborator

Study Sites (3)

Mixco, La Comunidad City Hall

Guatemala City, Guatemala

Location

Sacatepequez City Hall

Guatemala City, Guatemala

Location

Santa Catarina Pinula City Hall

Guatemala City, Guatemala

Location

Related Publications (1)

• Ford JL, Green JB, Haskell MJ, Ahmad SM, Mazariegos Cordero DI, Oxley A, Engle-Stone R, Lietz G, Green MH. Use of Model-Based Compartmental Analysis and a Super-Child Design to Study Whole-Body Retinol Kinetics and Vitamin A Total Body Stores in Children from 3 Lower-Income Countries. J Nutr. 2020 Feb 1;150(2):411-418. doi: 10.1093/jn/nxz225.

  PMID: 31535129 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood will be drawn on Day 4 post C-13 Vitamin A administration (women and children) and one variable day (children only) to obtain plasma, serum, and buffy coat (Day 4), or only plasma on variable day post Vitamin A dose for children.

Study Officials

• Dora I Mazariegos, MsSc

  Institute of Nutrition of Central America and Panama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Nutritional Biochemistry Laboratory

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: November 17, 2017
• Study Start: January 13, 2017
• Primary Completion: September 13, 2017
• Study Completion: October 30, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will become available when, after study data collection is finished, data are cleaned and analyzed.
• Access Criteria: All pre-defined researchers will have access to database. This includes Georg Lietz, principal coordinator, and local Principal researchers.

Locations

GU (3)