Clinical trial NCT01947426: Effect of Mother DHA Supplementation on Term Newborn.
Official title: Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Oxidative Stress
Inflammation
Infant Development
Keywords: DHA, term neonates, mother milk
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Puleva Biotech
First posted: 2013-09-20
Enrollment: 120
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change of Visual Development of newborn
timeFrame: Change from Baseline at 12 months of life
Secondary outcomes:
measure: Change of bone turnover biomarkers in blood samples during supplementation
timeFrame: Change from Baseline after supplementation (2,5 months)
measure: Change of oxidative stress parameters in mother milk samples during supplementation
timeFrame: Change from Baseline after supplementation (2,5 months)
measure: Motor and cognitive development of newborn
timeFrame: 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Julio J. Ochoa
Study officials:
affiliation: Universidad de Granada
name: Julio J Ochoa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.