Effect of Mother DHA Supplementation on Term Newborn.

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947426
• Other study ID #: C3565-00
• Secondary ID: C3565-00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 4, 2013
• Last updated: September 17, 2013
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: September 2013
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant Development
• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• DHA Supplementation
mothers consuming 400 mg of DHA/day and their neonates
• Control (milk without DHA)
mothers consuming placebo product and their neonates

Locations

Country	Name	City	State
Spain	Julio J. Ochoa	Granada

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Granada	Puleva Biotech

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Visual Development of newborn	Visual Evoked Potentials	Change from Baseline at 12 months of life	No
Secondary	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)	No
Secondary	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)	No
Secondary	Motor and cognitive development of newborn	Bayleys test	12 months	No