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

Completed

• Conditions: Vitamin A Status
• Interventions: Other: High VA intake, recent VAS; Other: High VA intake; Other: Low/adequate VA intake

• Registration Number: NCT03030339
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-25
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: High VA intake, recent VAS	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
Group 2: High VA intake	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.
Group 3: Low/adequate VA intake	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.

Primary Outcome Measures

Name	Time	Method
Total dietary vitamin A intake among children 12-18 mo of age	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)	15-day study period	Estimating using the dose-to-mother deuterium dilution technique.
Total body vitamin A stores among children 12-18 mo of age	28-day study period	Estimated using the 13C-retinol dilution method

Secondary Outcome Measures

Name	Time	Method
Liver function markers among children 12-18 mo of age	28-day study period
Consumption of fortifiable foods among women	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
Plasma or serum retinol-binding protein among children 12-18 mo of age	28-day study period
Total vitamin A intake among women	28-day study period	Estimated using 24-hour dietary recalls and food frequency questionnaires
Consumption of fortifiable foods among children	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
Transthyretin among children 12-18 mo of age	28-day study period
Retinol metabolites among children 12-18 mo of age	28-day study period
Plasma or serum retinol 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
Bone health markers among children 12-18 mo of age	28-day study period
Breast milk vitamin A concentration among lactating women	28-day study period

Trial Locations

Locations (1)

Block 37 Health Center; 🇵🇭 Mandaluyong, National Capital Region, Philippines