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Completed

NCT Number: NCT01947426

Effect of Mother DHA Supplementation on Term Newborn.

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.

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Key information

Conditions

Oxidative Stress Infant Development Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 40 year

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Julio J. Ochoa

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Consent
  • mother with normal gestation.

Exclusion criteria

  • Risk factors during gestation.
  • Lactose intolerance
  • systemic illness.
  • Kwashiorkor.
  • Metabolic illness.
  • Foetal pathologies

Treatment and study plan

DHA Supplementation

Dietary Supplement

mothers consuming 400 mg of DHA/day and their neonates

Other names: Docosahexaenoic acid

Control (milk without DHA)

Dietary Supplement

mothers consuming placebo product and their neonates

Other names: Placebo group

Primary outcomes

  1. Change of Visual Development of newborn

    Time frame: Change from Baseline at 12 months of life

    Visual Evoked Potentials

Secondary outcomes

  1. Change of bone turnover biomarkers in blood samples during supplementation

    Time frame: Change from Baseline after supplementation (2,5 months)

    indicators of Bone turnover in the mother and their child

  2. Change of oxidative stress parameters in mother milk samples during supplementation

    Time frame: Change from Baseline after supplementation (2,5 months)

    oxidative stress parameters (indicators of oxidative stress to lipids and proteins and antioxidant defense)

  3. Motor and cognitive development of newborn

    Time frame: 12 months

    Bayleys test

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Puleva Biotech

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Sep 20, 2013
Registry last updated
Sep 20, 2013

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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