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

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT03030339

Collaborator

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

123

Enrollment

Location

Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin A Status	Other: High VA intake, recent VAS Other: High VA intake Other: Low/adequate VA 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.

Study Design

Study Type:

Observational

Actual Enrollment :

123 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 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 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 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 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 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.

Arm

Intervention/Treatment

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

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 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

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 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

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.

Outcome Measures

Primary Outcome Measures

Total body vitamin A stores among children 12-18 mo of age [28-day study period]
Estimated using the 13C-retinol dilution 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.

Secondary Outcome Measures

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]
Bone health markers among children 12-18 mo of age [28-day study period]
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
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
Total vitamin A intake among women [28-day study period]
Estimated using 24-hour dietary recalls and food frequency questionnaires
Breast milk vitamin A concentration among lactating women [28-day study period]

Other Outcome Measures

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]
Infant length-for-age z score [At recruitment]
Systemic inflammation among children [28-day study period]
Iron status among children [28-day study period]
Zinc status among children [28-day study period]
Hepatitis infection among children [28-day study period]
Genetic markers related to vitamin A metabolism among children [28-day study period]
Infant hemoglobin concentration [At enrollment]
Infant morbidity symptoms [28-day study period and previous 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 18 Months

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Block 37 Health Center	Mandaluyong	National Capital Region	Philippines

Investigators

Study Director: Georg Lietz, Newcastle University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT03030339

Other Study ID Numbers:

903681
OPP1115464

First Posted:

Jan 25, 2017

Last Update Posted:

May 4, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD: