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- Klinische proef NCT00642863
Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
The project focuses on brain-behavior effects depending on the timing of iron deficiency (ID) and iron repletion in human infants. Iron deficiency (ID) is the world's most common single nutrient disorder, differentially affecting pregnant women and infants everywhere. The study promises to be the first systematic investigation of brain and behavior effects of prenatal dietary iron deficiency in human infants. The design will support comparisons of brain/behavior effects depending on the timing and duration of ID. The study will assess reversibility of effects, depending on timing of ID and its treatment, and examine maternal vs. fetal iron regulatory mechanisms in placenta and white blood cells. State-of-the-art neurophysiologic and behavioral measures will test specific hypotheses regarding effects of ID on sensory, motor, cognitive, affective-social and regulatory functions related to impaired myelination of sensory/motor systems and altered structure, neurotransmitter function and neurometabolism in targeted brain regions (basal ganglia and hippocampus). The study will be conducted in China, a rapidly developing country where ID often occurs among pregnant women and infants in the absence of generalized undernutrition. Cord blood hemoglobin (Hb) and ferritin concentrations will be measured in 1300 rural full-term infants, with iron status determined again at 9 and 18 mo. Brain-behavior assessments in the perinatal period will involve 359 infants ("newborn cohort"): 59 with low Hb ("low birth iron" group) will receive iron; 200 with marginal Hb or low cord ferritin ("marginal birth iron" group) will be randomly assigned at 6 wk, 50 to iron therapy and 150 to vitamins only; and 100 with normal cord Hb and ferritin levels ("normal birth iron" group) will receive vitamins only. The remaining 763 infants with cord blood testing will form the "blood screen cohort." At 9 and 18 mo, the newborn cohort will be reassessed, along with IDA infants from the blood screen cohort - about 58 at 9 mo ("early postnatal IDA") and 48 at 18 mo ("late postnatal IDA"). Approximately 39 marginal-birth-iron vitamins only-treated infants in the newborn cohort may also have IDA at 9 mo ("combined ID"). IDA infants will be treated with vitamins with iron. Differential effects and/or reversibility depending on timing of ID or treatment could inform health policy and practice worldwide. However, the effects of prenatal iron deficiency have received very little study in human infants due in large part to previous thinking, no longer accepted, that the infant was protected. Up to 75% of pregnant women worldwide are anemic, with about half due to ID. An estimated 20-25% of 6- to 24-mo-old infants have IDA, and more have ID without anemia. Thus, the public health implications of study findings could be profound.
The project is expected to continue with a 5-year follow-up (Aug 2013-July 2017).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Children's Hospital, Zhejiang University School of Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- infants born at Maternity and Children's Hospitals of Fuyang city in China
- healthy term newborns from uncomplicated pregnancies for hematology screening
- healthy full-term singleton infants with cord Hb and ferritin in the low-marginal or normal range for developmental testing
Exclusion Criteria:
- perinatal complications
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Low birth iron
Infants with low birth iron who receive vitamins A and D + iron
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a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.)
and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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Experimenteel: Marginal birth iron 1
Infants with marginal birth iron randomized to receive vitamins A and D + iron
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a single daily dose of 1-2 mg/kg of elemental iron (5 mg from 6 wk to 9 mo and 15 mg from 9 to 18 mo.)
and 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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Actieve vergelijker: Marginal birth iron 2
Infants with marginal birth iron randomized to receive vitamins A and D without iron
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a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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Actieve vergelijker: Normal birth iron
Infants with normal birth iron who receive vitamins A and D without iron
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a single daily dose (liquid) of 1500 IU vitamin A and 500 IU vitamin D from 6 wk to 18 mo.
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Experimenteel: Combined ID
Marginal-birth-iron vitamins only-treated infants who have IDA at 9 mo.
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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Experimenteel: Early postnatal IDA
Infants with IDA at 9 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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Experimenteel: Late postnatal IDA
Infants with IDA at 18 months whose cord blood was collected at birth but who were not assessed and assigned to vitamins with or without iron at 6 weeks.
These infants were also not anemic when screened at 9 months.
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Infants who become iron deficient/anemic at 9 or 18 mo will take a single daily dose of 3 mg/kg of elemental iron for 3 months.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Infant behavior and development
Tijdsspanne: 6 weeks; 9 and 18 months
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6 weeks; 9 and 18 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Infant anemia
Tijdsspanne: 9 and 18 months
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9 and 18 months
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Low or marginal birth iron
Tijdsspanne: 6 weeks
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6 weeks
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Betsy Lozoff, MD, University of Michigan
- Studie directeur: Jie Shao, MD, Children's Hospital, Zhejiang University School of Medicine
- Studie directeur: Zhengyan Zhao, MD, Children's Hospital, Zhejiang University School of Medicine
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Metabole ziekten
- Hematologische ziekten
- Bloedarmoede, hypochroom
- Bloedarmoede
- Stoornissen in het ijzermetabolisme
- Bloedarmoede, ijzertekort
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Beschermende middelen
- Micronutriënten
- Behoudsmiddelen voor botdichtheid
- Antioxidanten
- Anticarcinogene middelen
- Vitamine D
- Vitaminen
- Vitamine A
- Retinol palmitaat
Andere studie-ID-nummers
- 2P01HD039386-06A1 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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