Trial | NCT01947426  Report issue

Title

Effect of Mother DHA Supplementation on Term Newborn.
Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fish oil ...

  • Study Participants

    120
In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.
The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later:

Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control.

Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values.

The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.
Study Started
Apr 30
2008
Primary Completion
Apr 30
2010
Study Completion
Apr 30
2011
Last Update
Sep 20
2013
Estimate

Dietary Supplement DHA Supplementation

mothers consuming 400 mg of DHA/day and their neonates

  • Other names: Docosahexaenoic acid

Dietary Supplement Control (milk without DHA)

mothers consuming placebo product and their neonates

  • Other names: Placebo group

DHA supplementation Experimental

mother consuming 400 mg/day of DHA and tehir neonates

Control (milk without DHA) Placebo Comparator

Mothers comsuming placebo and their neonates

Criteria 

Inclusion Criteria:

Consent
mother with normal gestation.

Exclusion Criteria:

Risk factors during gestation.
Lactose intolerance
systemic illness.
Kwashiorkor.
Metabolic illness.
Foetal pathologies
No Results Posted