Epigenetic Analysis of Malnutrition

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.]]>
Anthropometric MeasurementsBlood CollectionBlood Processing and TransportMother Enrollment Case Report FormELISA Kit Assay: C-Reactive ProteinELISA Kit Assay: FerritinPROVIDE Manual of Procedures ICDDR, BMaternal body mass index (BMI) and child delta height for age z-score (HAZ) and weight for age z-score (WAZ) at 52 weeks of age REG1B ELISA ELISA Kit Assay: Retinol Binding ProteinsCD14ELISA Kit Assay: Vitamin DPLASMA ZINC ASSAY SOPSmart Tubes for Phosphoflow with IL6Criteria for the PROVIDE Study are as follows: Inclusion Criteria Mother willing to sign informed consent form. Healthy infant aged 0 to 7 days old. No obvious congenital abnormalities or birth defects. No abnormal (frequency and consistency) stools since birth. Stable household with no plans to leave the area for the next one year. Exclusion Criteria Parents are not willing to have child vaccinated at the field clinic. Parents are not willing to have child's blood drawn. Parents are planning to enroll child into another clinical study during the time period of this trial. Mother not willing to have blood drawn and breast milk extracted. Parents not willing to have field research assistant in home two times per week. History of seizures or other apparent neurologic disorders. Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG). Infant has any sibling currently or previously enrolled in this study, including a twin. 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.]]>
PROVIDE Study start date: May 2011 PROVIDE Study completion date: November 2014 PROVIDE Primary completion date: October 2014 Epigenetic Analysis of Malnutrition Study high throughput sequencing start date: 2013 Epigenetic Analysis of Malnutrition Study sequencing end date: 2014]]>