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Completed

NCT Number: NCT01811641

Methyl-Donors and EpiGenetics in The Gambia

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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Key information

Age range

1 day–45 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

season, dietary intake

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical Research Council

Other Gov

Registry information

Official study title

Epigenesis in Humans: Can Maternal Methyl-donor-deficient Diets Induce Epigenetic Alterations in Their Offspring?

Acronym: MDEG

Important dates

Study start
2009
Primary completion
2012
Study completion
2015
First posted
Mar 14, 2013
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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