Vitamin A StatusGloVitAS-GUNCT03345147
Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers
An observational study of Vitamin A Status, run by Institute of Nutrition of Central America and Panama at 3 sites in Guatemala.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Status
- What is being tested?
- High Vitamin A intake and Normal Vitamin A intake
- How many people
- 178 participants
- Where
- 3 sitesGuatemala
- Study dates
- 13 Jan 2017to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- °Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases
Trial locations and contacts
3 sites in 1 country.
Guatemala3 sites
Mixco, La Comunidad City Hall
Guatemala City
Sacatepequez City Hall
Guatemala City
Santa Catarina Pinula City Hall
Guatemala City
About this study
Official title: LOAEL/NOAEL and UL Determination in Guatemala - Estimation of Vitamin A Stores in Children and Women and Correlation With Potential Toxicity Markers
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).
Read the detailed description
The goal of this study is to assess whether VA intakes above the tolerable upper intake level (UL) and exposure to multiple programs are associated with are associated with 1) exposure to multiple VA intervention programs, and 2) elevated liver vitamin A concentration and biomarkers of excess vitamin A. Guatemala was selected as a study site because the country has a long standing national fortification program for vitamin A in sugar (law since 1975, re-launched and maintained since the 90´s). Typically, fortified sugar is used in more than 90% of households at average concentrations of 9 to 10 µg/g of sugar. VA fortified foods, in the form of fortified sugar, foods prepared with fortified sugar and other fortified foods, reach children from 2 years old to adulthood. On the other hand, high dose VA supplements, provided by local health services, only reached 10.5% of children ages 6-59 month in 2013. Children ages 2-3 and 4-5 years old with VA intakes above and below the UL will be recruited together with their mothers to assess the cumulative effect of fortification on young children and their mothers. Data from Program of Food and Nutrition Security (PROSAN), of the Ministry of Health, Guatemala in 2013, shows that coverage in the 30 Health Areas of the country is 17.9%, the lowest is 4.4% (San Marcos) and the largest 33% (Petén). Four of the 30 Region Areas correspond to the Department of Guatemala, in which urban and peri-urban areas of Guatemala City are included. In Central and North-West Guatemala Areas, coverage is 23 and 22% respectively, both above national average coverage and within the 10 out of 30 top coverages. According to PROSAN data for Micronutrient Powders in 2013, all four regions North-East, North-West, South, and Central Guatemala areas are also around or above the national coverage (14%) with 21.8, 11.2, 17.3 and 13.8% coverage. Another advantage of remaining in the 4 areas of Health around Guatemala city is that the four combined amount for 300,000 children of 0-59 month-old, that is more than 15% of the national children population reported. Even if coverages are low, population density will easier children recruitment.
- Conditions
- Vitamin A Status
- Being tested
- High Vitamin A intake, Normal Vitamin A intake
- Keywords
- Vitamin A, Isotopic dilution, dietary assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Vitamin A intakeOther
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 intakeOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High Vitamin A intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 28-day study period
Secondary outcomes (9)
Plasma retinol among 3-5 years-old children
Estimated by High Performance Liquid Chromatography (HPLC)
Measured: 28-day study period
Plasma retinol binding protein among 3-5 years-old children
Estimated by ELISA
Measured: 28-day study period
Plasma Transthyretin among 3-5 years-old children
Estimated by immunometric automated assay
Measured: 28-day study period
Bone Health markers among 3-5 years-old children
Estimated by different techniques
Measured: 28-day study period
Liver function markers among 3-5 years-old children
Estimated by different techniques
Measured: 28-day study period
Plasma retinol among women
Estimated by HPLC
Measured: 28-day study period
Plasma retinol binding protein among women
Estimated by ELISA
Measured: 28-day study period
Plasma Transthyretin among women
Estimated by immunometric automated assay
Measured: 28-day study period
Total dietary vitamin A intake among women, in micrograms (ug)
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
Measured: 28-day study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start13 Jan 2017
- Primary completion13 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition of Central America and Panama
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Bill and Melinda Gates Foundation, International Atomic Energy Agency
- Responsible party
- Principal investigator, Dora Ines Mazariegos, MSc, Institute of Nutrition of Central America and Panama
- Investigators
- Dora I Mazariegos, MsSc, Principal investigator, Institute of Nutrition of Central America and Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345147
- Sponsor's protocol ID
- CIE-REV 061/2016
- Acronym
- GloVitAS-GU
- Status last verified
- Nov 2017
- First submitted
- 25 Aug 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Collected individual participant data (IPD) will be shared within the researchers group of the Global Project (GLOVITAS, leaded by Newcastle University). Only initials will identify individual participants and the information shared will be on biochemical markers, diet, and general socioeconomic data.
Publications
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.
PubMed 31535129
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOAEL/NOAEL and UL Determination in Guatemala - Estimation of Vitamin A Stores in Children and Women and Correlation With Potential Toxicity Markers
- ClinicalTrials.gov ID
- NCT03345147
- Acronym / sponsor ID
- GloVitAS-GU / CIE-REV 061/2016
- Conditions
- Vitamin A Status
- Keywords
- Vitamin A, Isotopic dilution, dietary assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Institute of Nutrition of Central America and PanamaUniversity, hospital or other
- Collaborators
- Newcastle University, Bill and Melinda Gates Foundation, International Atomic Energy Agency
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The goal of this study is to assess whether VA intakes above the tolerable upper intake level (UL) and exposure to multiple programs are associated with are associated with 1) exposure to multiple VA intervention programs, and 2) elevated liver vitamin A concentration and biomarkers of excess vitamin A. Guatemala was selected as a study site because the country has a long standing national fortification program for vitamin A in sugar (law since 1975, re-launched and maintained since the 90´s). Typically, fortified sugar is used in more than 90% of households at average concentrations of 9 to 10 µg/g of sugar. VA fortified foods, in the form of fortified sugar, foods prepared with fortified sugar and other fortified foods, reach children from 2 years old to adulthood. On the other hand, high dose VA supplements, provided by local health services, only reached 10.5% of children ages 6-59 month in 2013. Children ages 2-3 and 4-5 years old with VA intakes above and below the UL will be recruited together with their mothers to assess the cumulative effect of fortification on young children and their mothers. Data from Program of Food and Nutrition Security (PROSAN), of the Ministry of Health, Guatemala in 2013, shows that coverage in the 30 Health Areas of the country is 17.9%, the lowest is 4.4% (San Marcos) and the largest 33% (Petén). Four of the 30 Region Areas correspond to the Department of Guatemala, in which urban and peri-urban areas of Guatemala City are included. In Central and North-West Guatemala Areas, coverage is 23 and 22% respectively, both above national average coverage and within the 10 out of 30 top coverages. According to PROSAN data for Micronutrient Powders in 2013, all four regions North-East, North-West, South, and Central Guatemala areas are also around or above the national coverage (14%) with 21.8, 11.2, 17.3 and 13.8% coverage. Another advantage of remaining in the 4 areas of Health around Guatemala city is that the four combined amount for 300,000 children of 0-59 month-old, that is more than 15% of the national children population reported. Even if coverages are low, population density will easier children recruitment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Vitamin A intake | – | Other: Normal Vitamin A intakeNormal 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. |
| High Vitamin A intake | – | Other: High Vitamin A intakeHigh 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- °Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Vitamin A intakeTotal 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). | Other | High Vitamin A intake |
| Normal Vitamin A intakeTotal 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). | Other | Normal Vitamin A intake |
Primary outcome
Total Vitamin A stores among 3-5 years-old children, in micromoles
Time frame: 28-day study period
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.
Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug)
Time frame: 28-day study period
Estimated using 24-hour dietary recalls, observed weigh food records, food and supplement frequency questionnaire
9 secondary outcomes
Plasma retinol among 3-5 years-old children
Time frame: 28-day study period
Plasma retinol binding protein among 3-5 years-old children
Time frame: 28-day study period
Plasma Transthyretin among 3-5 years-old children
Time frame: 28-day study period
Bone Health markers among 3-5 years-old children
Time frame: 28-day study period
Liver function markers among 3-5 years-old children
Time frame: 28-day study period
Plasma retinol among women
Time frame: 28-day study period
Plasma retinol binding protein among women
Time frame: 28-day study period
Plasma Transthyretin among women
Time frame: 28-day study period
Total dietary vitamin A intake among women, in micrograms (ug)
Time frame: 28-day study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 31535129Ford 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.
- Individual participant dataSharing planned: Yes. All Collected individual participant data (IPD) will be shared within the researchers group of the Global Project (GLOVITAS, leaded by Newcastle University). Only initials will identify individual participants and the information shared will be on biochemical markers, diet, and general socioeconomic data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dora I Mazariegos, MsSc principal investigator
Institute of Nutrition of Central America and Panama
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin A Status, run by Institute of Nutrition of Central America and Panama at 3 sites in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Vitamin A stores among 3-5 years-old children, in micromoles (time frame: 28-day study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.