ID

45798

Description

Principal Investigator: MeSH: Stunting,Growth Disorders,Malnutrition,Epigenomics,Virus Diseases,Parasitic Diseases,Digestive System Diseases,Respiratory Tract Diseases,Nervous System Diseases,Nutritional and Metabolic Diseases,Immune System Diseases,Disorders of Environmental Origin https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001073 The PROVIDE study (Dhaka, Bangladesh) is a randomized clinical trial platform which evaluated the efficacy of delayed-dose oral rotavirus vaccine as well as the benefit of an injectable polio vaccine replacing one dose of oral polio vaccine. This rigorous infrastructure supported the additional examination of hypotheses of vaccine underperformance. Primary and secondary efficacy and immunogenicity measures for rotavirus and polio vaccines were measured, as well as the impact of maternal and childhood malnutrition, environmental enteropathy, and additional exploratory variables. This study has been conducted to test the role of epigenetics in malnutrition, specifically the genome-wide role of histone modifications, which are known to provide a precise signature of metabolic state and immune system function.

Link

dbGaP-study=phs001073

Keywords

  1. 6/23/23 6/23/23 - Chiara Middel
Copyright Holder

David Auble, Ph.D. Department of Biochemistry and Molecular Genetics, University of Virginia Health System, Charlottesville, VA, USA; William Petri, M.D., Ph.D. Division of Infectious Diseases and International Health, University of Virginia Health Systema, Charlottesville, VA, USA; Rashidul Haque, M.B., Ph.D. International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh

Uploaded on

June 23, 2023

DOI

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License

Creative Commons BY 4.0

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    dbGaP phs001073 Epigenetic Analysis of Malnutrition

    Eligibility Criteria

    Inclusion and exclusion criteria
    Description

    Inclusion and exclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    Criteria for the PROVIDE Study are as follows: Inclusion Criteria <br>
    Description

    Elig.phs001073.v2.p1.1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    Mother willing to sign informed consent form.
    Description

    Elig.phs001073.v2.p1.2

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0600109
    UMLS CUI [1,3]
    C0021430
    Healthy infant aged 0 to 7 days old.
    Description

    Elig.phs001073.v2.p1.3

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3898900
    UMLS CUI [1,2]
    C0021270
    UMLS CUI [1,3]
    C0001779
    No obvious congenital abnormalities or birth defects.
    Description

    Elig.phs001073.v2.p1.4

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0000768
    No abnormal (frequency and consistency) stools since birth.
    Description

    Elig.phs001073.v2.p1.5

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C0015733
    UMLS CUI [1,4]
    C1711239
    UMLS CUI [1,5]
    C0005615
    Stable household with no plans to leave the area for the next one year. <br> Exclusion Criteria <br>
    Description

    Elig.phs001073.v2.p1.6

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205360
    UMLS CUI [1,2]
    C0020052
    UMLS CUI [1,3]
    C1298908
    UMLS CUI [1,4]
    C1301732
    UMLS CUI [1,5]
    C2699029
    UMLS CUI [2,1]
    C0680251
    Parents are not willing to have child vaccinated at the field clinic.
    Description

    Elig.phs001073.v2.p1.7

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030551
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0008059
    UMLS CUI [1,4]
    C0042196
    UMLS CUI [1,5]
    C0442592
    Parents are not willing to have child's blood drawn.
    Description

    Elig.phs001073.v2.p1.8

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030551
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0008059
    UMLS CUI [1,4]
    C0005834
    Parents are planning to enroll child into another clinical study during the time period of this trial.
    Description

    Elig.phs001073.v2.p1.9

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301732
    UMLS CUI [1,2]
    C0679823
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0008976
    UMLS CUI [1,5]
    C0347984
    UMLS CUI [1,6]
    C2347804
    Mother not willing to have blood drawn and breast milk extracted.
    Description

    Elig.phs001073.v2.p1.10

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0005834
    UMLS CUI [1,4]
    C0026131
    UMLS CUI [1,5]
    C0185115
    Parents not willing to have field research assistant in home two times per week.
    Description

    Elig.phs001073.v2.p1.11

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0030551
    UMLS CUI [1,2]
    C0558080
    UMLS CUI [1,3]
    C0035173
    UMLS CUI [1,4]
    C0020043
    UMLS CUI [1,5]
    C0205448
    UMLS CUI [1,6]
    C0456698
    History of seizures or other apparent neurologic disorders.
    Description

    Elig.phs001073.v2.p1.12

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0036572
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C0027765
    Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
    Description

    Elig.phs001073.v2.p1.13

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021270
    UMLS CUI [1,2]
    C2368628
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C2347804
    UMLS CUI [1,5]
    C1705847
    UMLS CUI [1,6]
    C0004886
    Infant has any sibling currently or previously enrolled in this study, including a twin.
    Description

    Elig.phs001073.v2.p1.14

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021270
    UMLS CUI [1,2]
    C1552551
    UMLS CUI [1,3]
    C0037047
    UMLS CUI [1,4]
    C0521116
    UMLS CUI [1,5]
    C1516879
    UMLS CUI [1,6]
    C0008976
    Criteria for the Epigenetic Analysis of Malnutrition study include meeting the inclusion criteria for the PROVIDE study and either being stunted (a height for age Z score of 2 standard deviations under the WHO's mean) or of normal height for age. These criteria were chosen so that meaningful differences in H3K4me3 expression could be detected between malnourished and well-nourished participants.
    Description

    Elig.phs001073.v2.p1.15

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C4329794
    UMLS CUI [1,3]
    C0936012
    UMLS CUI [1,4]
    C0162429
    UMLS CUI [1,5]
    C0008972
    UMLS CUI [1,6]
    C1516637
    UMLS CUI [1,7]
    C1550543
    UMLS CUI [1,8]
    C4230744
    UMLS CUI [1,9]
    C0587053
    UMLS CUI [2,1]
    C1511790
    UMLS CUI [2,2]
    C1705242
    UMLS CUI [2,3]
    C3846158
    UMLS CUI [2,4]
    C0017262
    UMLS CUI [2,5]
    C0162429
    UMLS CUI [2,6]
    C0517226
    UMLS CUI [2,7]
    C0679646

    Similar models

    Eligibility Criteria

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion and exclusion criteria
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    Elig.phs001073.v2.p1.1
    Item
    Criteria for the PROVIDE Study are as follows: Inclusion Criteria <br>
    boolean
    C1512693 (UMLS CUI [1,1])
    Elig.phs001073.v2.p1.2
    Item
    Mother willing to sign informed consent form.
    boolean
    C0026591 (UMLS CUI [1,1])
    C0600109 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [1,3])
    Elig.phs001073.v2.p1.3
    Item
    Healthy infant aged 0 to 7 days old.
    boolean
    C3898900 (UMLS CUI [1,1])
    C0021270 (UMLS CUI [1,2])
    C0001779 (UMLS CUI [1,3])
    Elig.phs001073.v2.p1.4
    Item
    No obvious congenital abnormalities or birth defects.
    boolean
    C1298908 (UMLS CUI [1,1])
    C0000768 (UMLS CUI [1,2])
    Elig.phs001073.v2.p1.5
    Item
    No abnormal (frequency and consistency) stools since birth.
    boolean
    C1298908 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C0015733 (UMLS CUI [1,3])
    C1711239 (UMLS CUI [1,4])
    C0005615 (UMLS CUI [1,5])
    Elig.phs001073.v2.p1.6
    Item
    Stable household with no plans to leave the area for the next one year. <br> Exclusion Criteria <br>
    boolean
    C0205360 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C1298908 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    C2699029 (UMLS CUI [1,5])
    C0680251 (UMLS CUI [2,1])
    Elig.phs001073.v2.p1.7
    Item
    Parents are not willing to have child vaccinated at the field clinic.
    boolean
    C0030551 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0008059 (UMLS CUI [1,3])
    C0042196 (UMLS CUI [1,4])
    C0442592 (UMLS CUI [1,5])
    Elig.phs001073.v2.p1.8
    Item
    Parents are not willing to have child's blood drawn.
    boolean
    C0030551 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0008059 (UMLS CUI [1,3])
    C0005834 (UMLS CUI [1,4])
    Elig.phs001073.v2.p1.9
    Item
    Parents are planning to enroll child into another clinical study during the time period of this trial.
    boolean
    C1301732 (UMLS CUI [1,1])
    C0679823 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    C0347984 (UMLS CUI [1,5])
    C2347804 (UMLS CUI [1,6])
    Elig.phs001073.v2.p1.10
    Item
    Mother not willing to have blood drawn and breast milk extracted.
    boolean
    C0026591 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0005834 (UMLS CUI [1,3])
    C0026131 (UMLS CUI [1,4])
    C0185115 (UMLS CUI [1,5])
    Elig.phs001073.v2.p1.11
    Item
    Parents not willing to have field research assistant in home two times per week.
    boolean
    C0030551 (UMLS CUI [1,1])
    C0558080 (UMLS CUI [1,2])
    C0035173 (UMLS CUI [1,3])
    C0020043 (UMLS CUI [1,4])
    C0205448 (UMLS CUI [1,5])
    C0456698 (UMLS CUI [1,6])
    Elig.phs001073.v2.p1.12
    Item
    History of seizures or other apparent neurologic disorders.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0036572 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C0027765 (UMLS CUI [1,4])
    Elig.phs001073.v2.p1.13
    Item
    Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
    boolean
    C0021270 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C2347804 (UMLS CUI [1,4])
    C1705847 (UMLS CUI [1,5])
    C0004886 (UMLS CUI [1,6])
    Elig.phs001073.v2.p1.14
    Item
    Infant has any sibling currently or previously enrolled in this study, including a twin.
    boolean
    C0021270 (UMLS CUI [1,1])
    C1552551 (UMLS CUI [1,2])
    C0037047 (UMLS CUI [1,3])
    C0521116 (UMLS CUI [1,4])
    C1516879 (UMLS CUI [1,5])
    C0008976 (UMLS CUI [1,6])
    Elig.phs001073.v2.p1.15
    Item
    Criteria for the Epigenetic Analysis of Malnutrition study include meeting the inclusion criteria for the PROVIDE study and either being stunted (a height for age Z score of 2 standard deviations under the WHO's mean) or of normal height for age. These criteria were chosen so that meaningful differences in H3K4me3 expression could be detected between malnourished and well-nourished participants.
    boolean
    C1512693 (UMLS CUI [1,1])
    C4329794 (UMLS CUI [1,2])
    C0936012 (UMLS CUI [1,3])
    C0162429 (UMLS CUI [1,4])
    C0008972 (UMLS CUI [1,5])
    C1516637 (UMLS CUI [1,6])
    C1550543 (UMLS CUI [1,7])
    C4230744 (UMLS CUI [1,8])
    C0587053 (UMLS CUI [1,9])
    C1511790 (UMLS CUI [2,1])
    C1705242 (UMLS CUI [2,2])
    C3846158 (UMLS CUI [2,3])
    C0017262 (UMLS CUI [2,4])
    C0162429 (UMLS CUI [2,5])
    C0517226 (UMLS CUI [2,6])
    C0679646 (UMLS CUI [2,7])

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