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

University of California (UC) Davis

Status: Completed

Conditions: Vitamin A Status

Treatments: Other: Low/adequate VA intake; Other: High VA intake, recent VAS; Other: High VA intake

Study type: Observational

Funder types: Other

Identifiers

NCT03030339

OPP1115464 (Other Grant/Funding Number)

903681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

123 participants in 3 patient groups

Group 1: High VA intake, recent VAS

Description:

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

Treatment:

Other: High VA intake, recent VAS

Group 2: High VA intake

Description:

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.

Treatment:

Other: High VA intake

Group 3: Low/adequate VA intake

Description:

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.

Treatment:

Other: Low/adequate VA intake