Methyl-Donors and EpiGenetics in The Gambia (MDEG)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Branwen Hennig, Medical Research Council
ClinicalTrials.gov Identifier:
NCT01811641
First received: March 11, 2013
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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 Intervention
Aberrant DNA Methylation
Other: season, dietary intake

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?

Further study details as provided by Medical Research Council:

Primary Outcome Measures:
  • DNA methylation of infants [ Time Frame: infants: at 3-6 months of age ] [ Designated as safety issue: No ]

    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:
  • Blood biomarker status of women [ Time Frame: monthly for 12 months or in early pregnancy ] [ Designated as safety issue: No ]
    Measurement of blood biomarkers monthly after dietary assessment or in early pregnancy


Biospecimen Retention:   Samples With DNA

blood, buccal swab, hair follicles


Estimated Enrollment: 500
Study Start Date: January 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
maternal methyl-donors, infant epigenetics
women of reproductive age in rural Gambia, infants born to these women
Other: season, dietary intake

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
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)

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided by Medical Research Council

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Branwen Hennig, MRC Senior Investigator Scientist, Medical Research Council
ClinicalTrials.gov Identifier: NCT01811641     History of Changes
Other Study ID Numbers: MRC-ING-MDEG
Study First Received: March 11, 2013
Last Updated: March 12, 2013
Health Authority: Gambia: MRC Ethics Committee

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

ClinicalTrials.gov processed this record on August 26, 2014