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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03030339 |
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Date of registration:
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17/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children
GloVitAS-P |
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Scientific title:
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Vitamin A Status and Risk of Excessive Vitamin A Intake Among Urban Filipino Children Exposed to Multiple Vitamin A Intervention Programs |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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123 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03030339 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Georg Lietz |
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Address:
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Telephone:
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Email:
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Affiliation:
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Newcastle University |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Months
Age maximum:
18 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin A Status
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Intervention(s)
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Other: High VA intake
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Other: High VA intake, recent VAS
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Other: Low/adequate VA intake
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Primary Outcome(s)
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Total breast milk intake (among breastfeeding children 12-18 mo of age)
[Time Frame: 15-day study period]
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Total dietary vitamin A intake among children 12-18 mo of age
[Time Frame: 28-day study period]
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Total body vitamin A stores among children 12-18 mo of age
[Time Frame: 28-day study period]
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Secondary Outcome(s)
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Consumption of fortifiable foods among women
[Time Frame: 28 day study period]
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Ratio of retinol to retinol-binding protein among children 12-18 mo of age
[Time Frame: 28-day study period]
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Consumption of fortifiable foods among children
[Time Frame: 28 day study period]
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Plasma or serum retinol among children 12-18 mo of age
[Time Frame: 28-day study period]
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Plasma or serum retinol-binding protein among children 12-18 mo of age
[Time Frame: 28-day study period]
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Breast milk vitamin A concentration among lactating women
[Time Frame: 28-day study period]
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Liver function markers among children 12-18 mo of age
[Time Frame: 28-day study period]
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Retinol metabolites among children 12-18 mo of age
[Time Frame: 28-day study period]
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Transthyretin among children 12-18 mo of age
[Time Frame: 28-day study period]
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Total vitamin A intake among women
[Time Frame: 28-day study period]
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Bone health markers among children 12-18 mo of age
[Time Frame: 28-day study period]
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Secondary ID(s)
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903681
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OPP1115464
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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