- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00642863
Brain and Behavior Depending on Timing of Iron Deficiency in Human Infants
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310003
- Children's Hospital, Zhejiang University School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Low birth iron
Infants with low birth iron who receive vitamins A and D + iron
|
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.
|
Eksperimentell: 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.
|
Aktiv komparator: 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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Aktiv komparator: 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.
|
Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Infant behavior and development
Tidsramme: 6 weeks; 9 and 18 months
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6 weeks; 9 and 18 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Infant anemia
Tidsramme: 9 and 18 months
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9 and 18 months
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Low or marginal birth iron
Tidsramme: 6 weeks
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6 weeks
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Betsy Lozoff, MD, University of Michigan
- Studieleder: Jie Shao, MD, Children's Hospital, Zhejiang University School of Medicine
- Studieleder: Zhengyan Zhao, MD, Children's Hospital, Zhejiang University School of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Metabolske sykdommer
- Hematologiske sykdommer
- Anemi, hypokromisk
- Anemi
- Forstyrrelser i jernmetabolisme
- Anemi, jernmangel
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Beskyttende agenter
- Mikronæringsstoffer
- Bone Density Conservation Agents
- Antioksidanter
- Antikreftfremkallende midler
- Vitamin d
- Vitaminer
- Vitamin A
- Retinolpalmitat
Andre studie-ID-numre
- 2P01HD039386-06A1 (U.S. NIH-stipend/kontrakt)
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