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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: |
NCT02498886 |
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Date of registration:
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13/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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IHAT Absorption Kinetics
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Scientific title:
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An Exploratory Study to Determine Bioavailability and Transferrin Saturation Following a Single Dose of a Novel Iron Supplement (IHAT) in Gambian Women. |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02498886 |
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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: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Early Phase 1
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Countries of recruitment
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Gambia
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Contacts
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Name:
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Dora I Pereira, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Research Council |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pre-menopausal women apparently healthy (as judged by a study nurse at the screening
day) with normal CRP (measured at screening).
- Non-pregnant (will be tested with a rapid pregnancy test) and non-lactating women.
- IDA arm: 9=Hb=11 g/dL and ferritin= 15 ng/ml
- Non-IDA arm: Hb>11 g/dL and ferritin> 15 ng/ml.
Exclusion Criteria:
- Malaria and other infections
- Severe anaemia (Hb<9 g/dL)
- CRP> 5 mg/L
- Chronic disease
- Currently participating in other iron intervention studies.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Iron-deficiency Anemia
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Intervention(s)
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Dietary Supplement: IHAT
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Dietary Supplement: Ferrous sulphate
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Primary Outcome(s)
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Relative bioavailability value of IHAT versus ferrous sulphate
[Time Frame: 14 days]
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Secondary Outcome(s)
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Plasma iron
[Time Frame: 6 hours]
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Transferrin saturation
[Time Frame: 6 hours]
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Pathogen Growth
[Time Frame: 6 hours]
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Serum iron
[Time Frame: 6 hours]
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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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