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Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children (GloVitAS-P)

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ClinicalTrials.gov Identifier: NCT03030339
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : May 4, 2017
Sponsor:
Collaborators:
Newcastle University
Penn State University
Helen Keller International
Philippines Food and Nutrition Research Institute
Global Alliance for Improved Nutrition
Bill and Melinda Gates Foundation
International Atomic Energy Agency
Information provided by (Responsible Party):
University of California, Davis

Brief 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 to children 12-18 months of age who have adequate vitamin A intake.

Condition or disease Intervention/treatment
Vitamin A Status Other: High VA intake, recent VAS Other: High VA intake Other: Low/adequate VA 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.

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Study Type : Observational
Actual Enrollment : 123 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs
Study Start Date : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Group/Cohort Intervention/treatment
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
Other: High VA intake, recent VAS
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.

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.
Other: High VA intake
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.

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.
Other: Low/adequate VA intake
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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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.


Secondary Outcome Measures :
  1. Plasma or serum retinol among children 12-18 mo of age [ Time Frame: 28-day study period ]
  2. Plasma or serum retinol-binding protein among children 12-18 mo of age [ Time Frame: 28-day study period ]
  3. Ratio of retinol to retinol-binding protein among children 12-18 mo of age [ Time Frame: 28-day study period ]
  4. Retinol metabolites among children 12-18 mo of age [ Time Frame: 28-day study period ]
  5. Transthyretin among children 12-18 mo of age [ Time Frame: 28-day study period ]
  6. Bone health markers among children 12-18 mo of age [ Time Frame: 28-day study period ]
  7. Liver function markers among children 12-18 mo of age [ Time Frame: 28-day study period ]
  8. Consumption of fortifiable foods among women [ Time Frame: 28 day study period ]
    Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool

  9. Consumption of fortifiable foods among children [ Time Frame: 28 day study period ]
    Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool

  10. Total vitamin A intake among women [ Time Frame: 28-day study period ]
    Estimated using 24-hour dietary recalls and food frequency questionnaires

  11. Breast milk vitamin A concentration among lactating women [ Time Frame: 28-day study period ]

Other Outcome Measures:
  1. Total food and nutrient intakes among women [ Time Frame: 28-day study period and 30 days prior to study period ]
  2. Total food and nutrient intakes among children [ Time Frame: 28-day study period and 30 days prior to study period ]
  3. Infant weight-for-length z score [ Time Frame: At recruitment ]
  4. Infant length-for-age z score [ Time Frame: At recruitment ]
  5. Systemic inflammation among children [ Time Frame: 28-day study period ]
  6. Iron status among children [ Time Frame: 28-day study period ]
  7. Zinc status among children [ Time Frame: 28-day study period ]
  8. Hepatitis infection among children [ Time Frame: 28-day study period ]
  9. Genetic markers related to vitamin A metabolism among children [ Time Frame: 28-day study period ]
  10. Infant hemoglobin concentration [ Time Frame: At enrollment ]
  11. Infant morbidity symptoms [ Time Frame: 28-day study period and previous 7 days ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, red and white cells, dried blood spots, breast milk


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 12-18 months of age and their mothers in selected neighborhoods in the National Capital Region of the Philippines
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030339


Locations
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Philippines
Block 37 Health Center
Mandaluyong, National Capital Region, Philippines
Sponsors and Collaborators
University of California, Davis
Newcastle University
Penn State University
Helen Keller International
Philippines Food and Nutrition Research Institute
Global Alliance for Improved Nutrition
Bill and Melinda Gates Foundation
International Atomic Energy Agency
Investigators
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Study Director: Georg Lietz Newcastle University

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03030339     History of Changes
Other Study ID Numbers: 903681
OPP1115464 ( Other Grant/Funding Number: Other )
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be determined.

Keywords provided by University of California, Davis:
Vitamin A status
infant
dietary assessment
retinol isotope dilution
breast milk intake

Additional relevant MeSH terms:
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Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents