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

Vitamin A Status Clinical Trial

— GloVitAS-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030339
• Other study ID #: 903681
• Secondary ID: OPP1115464
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: May 3, 2017
• Start date: August 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Vitamin A Status

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Philippines	Block 37 Health Center	Mandaluyong	National Capital Region

Sponsors (8)

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

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total food and nutrient intakes among women		28-day study period and 30 days prior to study period
Other	Total food and nutrient intakes among children		28-day study period and 30 days prior to study period
Other	Infant weight-for-length z score		At recruitment
Other	Infant length-for-age z score		At recruitment
Other	Systemic inflammation among children		28-day study period
Other	Iron status among children		28-day study period
Other	Zinc status among children		28-day study period
Other	Hepatitis infection among children		28-day study period
Other	Genetic markers related to vitamin A metabolism among children		28-day study period
Other	Infant hemoglobin concentration		At enrollment
Other	Infant morbidity symptoms		28-day study period and previous 7 days
Primary	Total body vitamin A stores among children 12-18 mo of age	Estimated using the 13C-retinol dilution method	28-day study period
Primary	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
Primary	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	Plasma or serum retinol among children 12-18 mo of age		28-day study period
Secondary	Plasma or serum retinol-binding protein among children 12-18 mo of age		28-day study period
Secondary	Ratio of retinol to retinol-binding protein among children 12-18 mo of age		28-day study period
Secondary	Retinol metabolites among children 12-18 mo of age		28-day study period
Secondary	Transthyretin among children 12-18 mo of age		28-day study period
Secondary	Bone health markers among children 12-18 mo of age		28-day study period
Secondary	Liver function markers among children 12-18 mo of age		28-day study period
Secondary	Consumption of fortifiable foods among women	Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool	28 day study period
Secondary	Consumption of fortifiable foods among children	Estimated by combining data from 24-hour recalls, observed weighed food records, food frequency questionnaires, and the Fortification Assessment Coverage Tool	28 day study period
Secondary	Total vitamin A intake among women	Estimated using 24-hour dietary recalls and food frequency questionnaires	28-day study period
Secondary	Breast milk vitamin A concentration among lactating women		28-day study period