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Completed

NCT Number: NCT03030339

Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children

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.

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Key information

Conditions

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Block 37 Health Center

Mandaluyong, National Capital Region, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High VA intake, recent VAS

Other

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 intake

Other

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 intake

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Food and Nutrition Research Institute, Philippines
  • Global Alliance for Improved Nutrition
  • Helen Keller International
  • International Atomic Energy Agency
  • Newcastle University
  • Penn State University

Registry information

Official study title

Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs

Acronym: GloVitAS-P

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2017
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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