Methyl-Donors and EpiGenetics in The Gambia (MDEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01811641
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : March 22, 2016
Information provided by (Responsible Party):
Matt Silver, Medical Research Council

March 11, 2013
March 14, 2013
March 22, 2016
January 2009
June 2012   (Final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01811641 on Archive Site
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
Same as current
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Methyl-Donors and EpiGenetics in The Gambia
Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
blood, buccal swab, hair follicles
Non-Probability Sample
women of reproductive age in rural Gambia and their infants
Aberrant DNA Methylation
Other: season, dietary intake
maternal methyl-donors, infant epigenetics
women of reproductive age in rural Gambia, infants born to these women
Intervention: Other: season, dietary intake

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2015
June 2012   (Final data collection date for primary outcome measure)

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)

Sexes Eligible for Study: All
up to 45 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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Matt Silver, Medical Research Council
Medical Research Council
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Medical Research Council
March 2016