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Methyl-Donors and EpiGenetics in The Gambia (MDEG)

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ClinicalTrials.gov Identifier: NCT01811641
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Accumulating evidence suggests that early-life nutrition can affect metabolism and thus increase the risk of disease in adulthood (e.g. type II diabetes and obesity). One possible mechanism to explain these effects is epigenetic variation at critical periods of development. Epigenetic variation describes non-inherited permanent alterations to an individuals DNA.

Recent work in mouse models has demonstrated that maternal nutritional status can affect such epigenetic processes such as DNA methylation and gene expression during embryonic development, with profound effects on outcomes. The investigators aim to study these processes in humans for the first time. The investigators will exploit the "experiment of nature" setting in The Gambia, i.e. fluctuation in diet according to season. During the 'hungry' season diets are known to be depleted in nutrients required for epigenetic gene regulation. Nutritional biomarkers in blood as well as the dietary intake will be measured in pregnant women according to season. A blood sample will also be taken from babies born to these women to determine whether there is a direct effect of diet on mothers' nutritional status and hence variation in DNA methylation patterns in their babies by season.


Condition or disease Intervention/treatment
Aberrant DNA Methylation Other: season, dietary intake

Study Design

Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?
Study Start Date : January 2009
Primary Completion Date : June 2012
Study Completion Date : December 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
maternal methyl-donors, infant epigenetics
women of reproductive age in rural Gambia, infants born to these women
Other: season, dietary intake


Outcome Measures

Primary Outcome Measures :
  1. DNA methylation of infants [ Time Frame: infants: at 3-6 months of age ]

    Measurement of DNA methylation of infants recruited into the study, at 3-6 months of age.

    Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy



Secondary Outcome Measures :
  1. Blood biomarker status of women [ Time Frame: monthly for 12 months or in early pregnancy ]
    Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy


Biospecimen Retention:   Samples With DNA
blood, buccal swab, hair follicles

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women of reproductive age in rural Gambia and their infants
Criteria

Inclusion criteria women:

- women aged 18-45 years on 15th March 2009, resident in West Kiang

Exclusion criteria women:

  • on contraception
  • confirmed pregnancy at recruitment
  • enrolment in any study other than the ENID (Early Nutrition and Immune Development) trial (ISRCTN49285450)
  • suffering from severe anaemia (haemoglobin <7 g/dl) or known sickle cell disease

Inclusion criteria infants:

- born to the above women

Exclusion criteria infants:

- those known to be severely malnourished (weight-for-height Z-score < -3)

More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matt Silver, MRC Senior Investigator Scientist, Medical Research Council
ClinicalTrials.gov Identifier: NCT01811641     History of Changes
Other Study ID Numbers: MRC-ING-MDEG
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

Keywords provided by Matt Silver, Medical Research Council:
season of conception
maternal nutritional status
infant DNA methylation