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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress; Infant Development
• Intervention / Treatment: Dietary supplement: DHA Supplementation; Dietary supplement: Control (milk without DHA)

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Julio J. Ochoa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DHA supplementation; mother consuming 400 mg/day of DHA and tehir neonates	Dietary supplement: DHA Supplementation; mothers consuming 400 mg of DHA/day and their neonates; Other Names: Docosahexaenoic acid
Placebo Comparator: Control (milk without DHA); Mothers comsuming placebo and their neonates	Dietary supplement: Control (milk without DHA); mothers consuming placebo product and their neonates; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Visual Development of newborn	Visual Evoked Potentials	Change from Baseline at 12 months of life

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Puleva Biotech
• Investigators: Principal Investigator: Julio J Ochoa, Universidad de Granada

Publications and helpful links

General Publications

• Hurtado JA, Iznaola C, Pena M, Ruiz J, Pena-Quintana L, Kajarabille N, Rodriguez-Santana Y, Sanjurjo P, Aldamiz-Echevarria L, Ochoa J, Lara-Villoslada F; NUGELA Group. Effects of Maternal Omega-3 Supplementation on Fatty Acids and on Visual and Cognitive Development. J Pediatr Gastroenterol Nutr. 2015 Oct;61(4):472-80. doi: 10.1097/MPG.0000000000000864.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): September 20, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: DHA, term neonates, mother milk
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: C3565-00 (Other Identifier: Lactalis PULEVA)