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

March 11, 2013
March 12, 2013
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 ] [ 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

Same as current
Complete list of historical versions of study NCT01811641 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Dominguez-Salas P, Moore SE, Cole D, da Costa KA, Cox SE, Dyer RA, Fulford AJ, Innis SM, Waterland RA, Zeisel SH, Prentice AM, Hennig BJ. DNA methylation potential: dietary intake and blood concentrations of one-carbon metabolites and cofactors in rural African women. Am J Clin Nutr. 2013 Jun;97(6):1217-27. doi: 10.3945/ajcn.112.048462. Epub 2013 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
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)

Both
up to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01811641
MRC-ING-MDEG
No
Branwen Hennig, Medical Research Council
Medical Research Council
Not Provided
Not Provided
Medical Research Council
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP