Effect of Mother DHA Supplementation on Term Newborn.

Phase 2

Completed

• Conditions: Oxidative Stress; Inflammation; Infant Development
• Interventions: Dietary Supplement: Control (milk without DHA); Dietary Supplement: DHA Supplementation

• Registration Number: NCT01947426
• Lead Sponsor: Universidad de Granada

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-04
• Primary Completion: 2010-04
• Study Completion: 2011-04
• Status Verified: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Study First Posted: 2013-09-20
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Consent
2. mother with normal gestation.

Exclusion Criteria

1. Risk factors during gestation.
2. Lactose intolerance
3. systemic illness.
4. Kwashiorkor.
5. Metabolic illness.
6. Foetal pathologies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (milk without DHA)	Control (milk without DHA)	Mothers comsuming placebo and their neonates
DHA supplementation	DHA Supplementation	mother consuming 400 mg/day of DHA and tehir neonates

Primary Outcome Measures

Name	Time	Method
Change of Visual Development of newborn	Change from Baseline at 12 months of life	Visual Evoked Potentials

Secondary Outcome Measures

Name	Time	Method
Change of bone turnover biomarkers in blood samples during supplementation	Change from Baseline after supplementation (2,5 months)	indicators of Bone turnover in the mother and their child
Change of oxidative stress parameters in mother milk samples during supplementation	Change from Baseline after supplementation (2,5 months)	oxidative stress parameters (indicators of oxidative stress to lipids and proteins and antioxidant defense)
Motor and cognitive development of newborn	12 months	Bayleys test

Trial Locations

Locations (1)

Julio J. Ochoa; 🇪🇸 Granada, Spain