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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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12 December 2020 |
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Main ID: |
NCT03000543 |
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Date of registration:
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14/12/2016 |
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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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Novel Isotope Dilution Technique to Assess Vitamin A Status
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Scientific title:
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Validation of a Novel Isotope Dilution Technique to Assess Vitamin A Status in Infants |
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Date of first enrolment:
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November 1, 2016 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03000543 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Shaikh M Ahmad, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. 9 - 18 months of age
2. Infants with normal body temperature and normal CRP (<5 mg/L)
3. Infants receive breast milk from the mother at least once per day
4. Mothers produce a breast milk containing 30-40 nmol vitamin A /g milk fat
5. Infants received a high-dose vitamin A capsules at the time of the most recent
national distribution campaign (within the last 2-4 months)
6. Mother is 18 - 45 years of age
7. Mother and her infant plan to stay in the study area for the duration of the study
Exclusion criteria:
1. Mother or infant has chronic disease
2. Mother or infant has acute illness on the day of data collection
3. Infant is anemic (Hb <90 g/L)
4. Infant has weight for length <80% of the reference median
5. Infants do not develop inflammation (CRP =5 mg/L) after PENTA vaccination
Age minimum:
9 Months
Age maximum:
18 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Healthy Infants
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Infants With an Inflammatory Condition
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Intervention(s)
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Biological: Vaccine
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Primary Outcome(s)
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Vitamin A pool size in infants with or without inflammation
[Time Frame: Kinetic study for 28 days for each of the 2 groups of infants]
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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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