ID

45798

Beschrijving

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

Trefwoorden

  1. 23-06-23 23-06-23 - Chiara Middel
Houder van rechten

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

Geüploaded op

23 juni 2023

DOI

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Licentie

Creative Commons BY 4.0

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dbGaP phs001073 Epigenetic Analysis of Malnutrition

Eligibility Criteria

Inclusion and exclusion criteria
Beschrijving

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>
Beschrijving

Elig.phs001073.v2.p1.1

Datatype

boolean

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

Elig.phs001073.v2.p1.2

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.3

Datatype

boolean

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

Elig.phs001073.v2.p1.4

Datatype

boolean

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

Elig.phs001073.v2.p1.5

Datatype

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>
Beschrijving

Elig.phs001073.v2.p1.6

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.7

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.8

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.9

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.10

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.11

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.12

Datatype

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).
Beschrijving

Elig.phs001073.v2.p1.13

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.14

Datatype

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.
Beschrijving

Elig.phs001073.v2.p1.15

Datatype

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)
Datatype
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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