Effect of Mother DHA Supplementation on Term Newborn.

NCT ID: NCT01947426

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2011-04-30

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.

Conditions

Oxidative Stress; Inflammation; Infant Development

Keywords

DHA, term neonates, mother milk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

DHA supplementation

mother consuming 400 mg/day of DHA and tehir neonates

Group Type: EXPERIMENTAL

DHA Supplementation

Intervention Type: DIETARY_SUPPLEMENT

mothers consuming 400 mg of DHA/day and their neonates

Control (milk without DHA)

Mothers comsuming placebo and their neonates

Group Type: PLACEBO_COMPARATOR

Control (milk without DHA)

Intervention Type: DIETARY_SUPPLEMENT

mothers consuming placebo product and their neonates

Interventions

DHA Supplementation

mothers consuming 400 mg of DHA/day and their neonates

Intervention Type: DIETARY_SUPPLEMENT

Control (milk without DHA)

mothers consuming placebo product and their neonates

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Docosahexaenoic acid; Placebo group

Eligibility Criteria

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

• Maximum Eligible Age: 40 Years
• Accepts Healthy Volunteers: Yes

Sponsors

Puleva Biotech

INDUSTRY

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Julio J. Ochoa

Julio J. Ochoa, Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julio J Ochoa

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Julio J. Ochoa

Granada, Granada, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 25988553 (View on PubMed)

Other Identifiers

C3565-00

Identifier Type: OTHER

Identifier Source: secondary_id

C3565-00

Identifier Type: -

Identifier Source: org_study_id