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

NCT03030339 | Completed

• 2 other identifiers: 903681OPP1115464
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin A Status

Keywords

Vitamin A status; infant; dietary assessment; retinol isotope dilution; breast milk intake

Outcome Measures

Primary Outcomes (3)

• Total body vitamin A stores among children 12-18 mo of age

  Estimated using the 13C-retinol dilution method

  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)

  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.

  15-day study period

Secondary Outcomes (11)

• Plasma or serum retinol among children 12-18 mo of age

  28-day study period

• Plasma or serum retinol-binding protein among children 12-18 mo of age

  28-day study period

• Ratio of retinol to retinol-binding protein among children 12-18 mo of age

  28-day study period

• Retinol metabolites among children 12-18 mo of age

  28-day study period

• Transthyretin among children 12-18 mo of age

  28-day study period

Other Outcomes (11)

• Total food and nutrient intakes among women

  28-day study period and 30 days prior to study period

• Total food and nutrient intakes among children

  28-day study period and 30 days prior to study period

• Infant weight-for-length z score

  At recruitment

Study Arms (3)

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

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

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

Interventions

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.

Group 1: High VA intake, recent VAS

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.

Group 2: High 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.

Group 3: Low/adequate VA intake

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Block 37 Health Center

Mandaluyong, National Capital Region, Philippines

Location

Related Publications (3)

• Engle-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.

  PMID: 36060221 DERIVED

• Oxley 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.

  PMID: 33755155 DERIVED

• 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

Serum, plasma, red and white cells, dried blood spots, breast milk

Study Officials

• Georg Lietz

  Newcastle University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 25, 2017
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

PH (1)