Vitamin A StatusGloVitAS-PNCT03030339
Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children
An observational study of Vitamin A Status, run by University of California, Davis at 1 site in Philippines.
Trial summary
The goal of this study is to assess whether children 12-18 months of age who are exposed to multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers of excessive vitamin A status, compared… Read more about this study
- Who is it for?
- Ages 12 to 18 months
- Conditions the study is for
- Vitamin A Status
- What is being tested?
- High VA intake, recent VAS, High VA intake and Low/adequate VA intake
- How many people
- 123 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2016to Mar 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 12 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Children 12-18 months of age and their mothers in selected neighborhoods in the National Capital Region of the Philippines
Who may be able to join
- Children 12-18 months of age, and their mothers (18-49 years of age)
- Living in selected communities in the National Capital Region of the Philippines
- The mother and child must plan to stay in the study area for the duration of the study.
- Child's estimated vitamin A intake and exposure to vitamin A programs must meet eligibility criteria for one of three groups, based on a screening questionnaire administered by an interviewer to the child's mother.
- Eligibility criteria for children in Group 1: 1) consumed MNP or a multi-vitamin preparation that contains vitamin A in the previous 7 days, 2) consumed at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule during the previous month, and 5) received a screening tool 'score' suggesting VA intake above 600 µg retinol/d.
- Eligibility criteria for children in Group 2: will include children who: 1) consumed MNP or a multi-vitamin A preparation that contains vitamin A in the previous 7 days, 2) consumed at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule in the previous 3-6 months, and 5) received a screening tool 'score' suggesting VA intake above 600 µg retinol/d.
- Eligibility criteria for children in Group 3: will include children who: 1) received a high dose VA capsule during the previous 3-6 months, and 2) received a screening tool 'score' suggesting VA intake 200-500 µg/d.
Who cannot join
- The child did not receive a high-dose VA capsule during the most recent national campaign
- The mother or child has chronic disease
- The child has moderate or severe anemia (Hb <10 g/dL)
- The mother or child has signs or symptoms of vitamin A deficiency (Bitot's spots, conjunctival xerosis, nightblindness)
- The child has weight for length < -2 z-scores of the median of the WHO growth standards
- The mother is breastfeeding more than one child
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Block 37 Health Center
Mandaluyong, National Capital Region
About this study
Official title: Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs
The goal of this study is to assess whether children 12-18 months of age who are exposed to multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers of excessive vitamin A status, compared to children 12-18 months of age who have adequate vitamin A intake.
Read the detailed description
This is an observational study with 3 groups, which are identified using a screening tool to obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods and supplements. Children and their mothers are studied over the course of one month to determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total breast milk intake (among breastfeeding children), using the dose-to-mother deuterium dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers of bone and liver health. Blood collection is structured in a "Super-Child" design, to construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition among children will be measured, in addition to the vitamin A intake and breast milk vitamin A concentration (for breastfeeding mothers) of the mother.
- Conditions
- Vitamin A Status
- Being tested
- High VA intake, recent VAS, High VA intake, Low/adequate VA intake
- Keywords
- Vitamin A status, infant, dietary assessment, retinol isotope dilution, breast milk intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High VA intake, recent VASOther
Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.
High VA intakeOther
Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.
Low/adequate VA intakeOther
Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: High VA intake, recent VAS | Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake Receives: Other: High VA intake, recent VAS | |
| Group 2: High VA intake | Children who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake. Receives: Other: High VA intake | |
| Group 3: Low/adequate VA intake | Children who are not exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake. Receives: Other: Low/adequate VA intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body vitamin A stores among children 12-18 mo of age
Estimated using the 13C-retinol dilution method
Measured: 28-day study period
Total dietary vitamin A intake among children 12-18 mo of age
Estimated using 24-hour dietary recalls, observed weighed food records, food and supplement frequency questionnaire, breast milk vitamin A concentration, and total breast milk intake (measured by the dose-to-mother deuterium dilution technique)
Measured: 28-day study period
Total breast milk intake (among breastfeeding children 12-18 mo of age)
Estimating using the dose-to-mother deuterium dilution technique.
Measured: 15-day study period
Secondary outcomes (11)
Plasma or serum retinol among children 12-18 mo of age
Measured: 28-day study period
Plasma or serum retinol-binding protein among children 12-18 mo of age
Measured: 28-day study period
Ratio of retinol to retinol-binding protein among children 12-18 mo of age
Measured: 28-day study period
Retinol metabolites among children 12-18 mo of age
Measured: 28-day study period
Transthyretin among children 12-18 mo of age
Measured: 28-day study period
Bone health markers among children 12-18 mo of age
Measured: 28-day study period
Liver function markers among children 12-18 mo of age
Measured: 28-day study period
Consumption of fortifiable foods among women
Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
Measured: 28 day study period
Consumption of fortifiable foods among children
Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool
Measured: 28 day study period
Total vitamin A intake among women
Estimated using 24-hour dietary recalls and food frequency questionnaires
Measured: 28-day study period
Breast milk vitamin A concentration among lactating women
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 posted25 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin A StatusStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Penn State University, Helen Keller International, Food and Nutrition Research Institute, Philippines, Global Alliance for Improved Nutrition, Bill and Melinda Gates Foundation, International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Georg Lietz, Study director, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030339
- Sponsor's protocol ID
- 903681
- Other IDs
- OPP1115464
- Acronym
- GloVitAS-P
- Status last verified
- May 2017
- First submitted
- 17 Jan 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: To be determined.
Publications
Lietz G, Oxley A. Formulation of Vitamin A Tracer Doses for Administration to Human Subjects using Retinol Isotope Dilution Technique. J Vis Exp. 2026 Mar 31;(229). doi: 10.3791/69240.
PubMed 42008529Engle-Stone R, Miller JC, Reario MFD, Arnold CD, Stormer A, Lafuente E, Oxley A, Capanzana MV, Cabanilla CVD, Ford JL, Clark A, Velavan TP, Brown KH, Lietz G, Haskell MJ. Filipino Children with High Usual Vitamin A Intakes and Exposure to Multiple Sources of Vitamin A Have Elevated Total Body Stores of Vitamin A But Do Not Show Clear Evidence of Vitamin A Toxicity. Curr Dev Nutr. 2022 Jul 25;6(8):nzac115. doi: 10.1093/cdn/nzac115. eCollection 2022 Aug.
PubMed 36060221Oxley A, Engle-Stone R, Miller JC, Reario MFD, Stormer A, Capanzana MV, Cabanilla CVD, Haskell MJ, Lietz G. Determination of Vitamin A Total Body Stores in Children from Dried Serum Spots: Application in a Low- and Middle-Income Country Community Setting. J Nutr. 2021 May 11;151(5):1341-1346. doi: 10.1093/jn/nxaa446.
PubMed 33755155Ford 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 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs
- ClinicalTrials.gov ID
- NCT03030339
- Acronym / sponsor ID
- GloVitAS-P / 903681
- Conditions
- Vitamin A Status
- Keywords
- Vitamin A status, infant, dietary assessment, retinol isotope dilution, breast milk intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Newcastle University, Penn State University, Helen Keller International, Food and Nutrition Research Institute, Philippines, Global Alliance for Improved Nutrition, Bill and Melinda Gates Foundation, International Atomic Energy Agency
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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 children 12-18 months of age who are exposed to multiple large-scale vitamin A programs, and who are likely to have vitamin A intakes above the tolerable upper intake level (UL), have higher total body vitamin A stores and biomarkers of excessive vitamin A status, compared to children 12-18 months of age who have adequate vitamin A intake.
Detailed description
This is an observational study with 3 groups, which are identified using a screening tool to obtain information on exposure to vitamin A programs and consumption of vitamin A-rich foods and supplements. Children and their mothers are studied over the course of one month to determine 1) child total body vitamin A stores, using the 13C retinol isotope dilution method, 2) the child's vitamin A intake, using multiple dietary assessment methods, 3) total breast milk intake (among breastfeeding children), using the dose-to-mother deuterium dilution method, and 4) potential biomarkers of excessive vitamin A status, including markers of bone and liver health. Blood collection is structured in a "Super-Child" design, to construct plasma retinol kinetic curves. Other indicators related to vitamin A nutrition among children will be measured, in addition to the vitamin A intake and breast milk vitamin A concentration (for breastfeeding mothers) of the mother.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: High VA intake, recent VAS | – | Other: High VA intake, recent VASChildren who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake |
| Group 2: High VA intake | – | Other: High VA intakeChildren who are exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake. |
| Group 3: Low/adequate VA intake | – | Other: Low/adequate VA intakeChildren who are not exposed to multiple vitamin A (VA) programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake. |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 12-18 months of age and their mothers in selected neighborhoods in the National Capital Region of the Philippines
Key inclusion criteria (7 listed)
- Children 12-18 months of age, and their mothers (18-49 years of age)
- Living in selected communities in the National Capital Region of the Philippines
- The mother and child must plan to stay in the study area for the duration of the study.
- Child's estimated vitamin A intake and exposure to vitamin A programs must meet eligibility criteria for one of three groups, based on a screening questionnaire administered by an interviewer to the child's mother.
- Eligibility criteria for children in Group 1: 1) consumed MNP or a multi-vitamin preparation that contains vitamin A in the previous 7 days, 2) consumed at least one fortified staple food (oil or wheat flour) in the previous 7 days, 3) consumed breast milk or fortified milk in the past 24 hours, 4) received a high-dose VA capsule during the previous month, and 5) received a screening tool 'score' suggesting VA intake above 600 µg retinol/d.
Key exclusion criteria (6 listed)
- The child did not receive a high-dose VA capsule during the most recent national campaign
- The mother or child has chronic disease
- The child has moderate or severe anemia (Hb <10 g/dL)
- The mother or child has signs or symptoms of vitamin A deficiency (Bitot's spots, conjunctival xerosis, nightblindness)
- The child has weight for length < -2 z-scores of the median of the WHO growth standards
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 VA intake, recent VASChildren who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake. | Other | Group 1: High VA intake, recent VAS |
| High VA intakeChildren who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake. | Other | Group 2: High VA intake |
| Low/adequate VA intakeChildren who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake. | Other | Group 3: Low/adequate VA intake |
Primary outcome
Total body vitamin A stores among children 12-18 mo of age
Time frame: 28-day study period
Estimated using the 13C-retinol dilution method
Total dietary vitamin A intake among children 12-18 mo of age
Time frame: 28-day study period
Estimated using 24-hour dietary recalls, observed weighed food records, food and supplement frequency questionnaire, breast milk vitamin A concentration, and total breast milk intake (measured by the dose-to-mother deuterium dilution technique)
Total breast milk intake (among breastfeeding children 12-18 mo of age)
Time frame: 15-day study period
Estimating using the dose-to-mother deuterium dilution technique.
11 secondary outcomes
Plasma or serum retinol among children 12-18 mo of age
Time frame: 28-day study period
Plasma or serum retinol-binding protein among children 12-18 mo of age
Time frame: 28-day study period
Ratio of retinol to retinol-binding protein among children 12-18 mo of age
Time frame: 28-day study period
Retinol metabolites among children 12-18 mo of age
Time frame: 28-day study period
Transthyretin among children 12-18 mo of age
Time frame: 28-day study period
Bone health markers among children 12-18 mo of age
Time frame: 28-day study period
Liver function markers among children 12-18 mo of age
Time frame: 28-day study period
Consumption of fortifiable foods among women
Time frame: 28 day study period
Consumption of fortifiable foods among children
Time frame: 28 day study period
Total vitamin A intake among women
Time frame: 28-day study period
Breast milk vitamin A concentration among lactating women
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 4 May 2017.
- Derived from this study: PubMed 42008529Lietz G, Oxley A. Formulation of Vitamin A Tracer Doses for Administration to Human Subjects using Retinol Isotope Dilution Technique. J Vis Exp. 2026 Mar 31;(229). doi: 10.3791/69240.
- Derived from this study: PubMed 36060221Engle-Stone R, Miller JC, Reario MFD, Arnold CD, Stormer A, Lafuente E, Oxley A, Capanzana MV, Cabanilla CVD, Ford JL, Clark A, Velavan TP, Brown KH, Lietz G, Haskell MJ. Filipino Children with High Usual Vitamin A Intakes and Exposure to Multiple Sources of Vitamin A Have Elevated Total Body Stores of Vitamin A But Do Not Show Clear Evidence of Vitamin A Toxicity. Curr Dev Nutr. 2022 Jul 25;6(8):nzac115. doi: 10.1093/cdn/nzac115. eCollection 2022 Aug.
- Derived from this study: PubMed 33755155Oxley A, Engle-Stone R, Miller JC, Reario MFD, Stormer A, Capanzana MV, Cabanilla CVD, Haskell MJ, Lietz G. Determination of Vitamin A Total Body Stores in Children from Dried Serum Spots: Application in a Low- and Middle-Income Country Community Setting. J Nutr. 2021 May 11;151(5):1341-1346. doi: 10.1093/jn/nxaa446.
- 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: Undecided. To be determined.
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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.
Georg Lietz study director
Newcastle University
1 site 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 University of California, Davis at 1 site in Philippines.
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 7 inclusion and 6 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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 body vitamin A stores among children 12-18 mo of age (time frame: 28-day study period). The study lists 3 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 NCT03030339, which also lists 4 linked publications.
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 4 May 2017.