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Effect of Mother DHA Supplementation on Term Newborn.

Primary Purpose

Oxidative Stress, Inflammation, Infant Development

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DHA Supplementation
Control (milk without DHA)
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oxidative Stress focused on measuring DHA, term neonates, mother milk

Eligibility Criteria

undefined - 40 Years (Child, Adult)Accepts Healthy Volunteers

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

Sites / Locations

  • Julio J. Ochoa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHA supplementation

Control (milk without DHA)

Arm Description

mother consuming 400 mg/day of DHA and tehir neonates

Mothers comsuming placebo and their neonates

Outcomes

Primary Outcome Measures

Change of Visual Development of newborn
Visual Evoked Potentials

Secondary Outcome Measures

Change of bone turnover biomarkers in blood samples during supplementation
indicators of Bone turnover in the mother and their child
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)
Motor and cognitive development of newborn
Bayleys test

Full Information

First Posted
September 4, 2013
Last Updated
September 17, 2013
Sponsor
Universidad de Granada
Collaborators
Puleva Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT01947426
Brief Title
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

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
Puleva Biotech

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Infant Development
Keywords
DHA, term neonates, mother milk

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA supplementation
Arm Type
Experimental
Arm Description
mother consuming 400 mg/day of DHA and tehir neonates
Arm Title
Control (milk without DHA)
Arm Type
Placebo Comparator
Arm Description
Mothers comsuming placebo and their neonates
Intervention Type
Dietary Supplement
Intervention Name(s)
DHA Supplementation
Other Intervention Name(s)
Docosahexaenoic acid
Intervention Description
mothers consuming 400 mg of DHA/day and their neonates
Intervention Type
Dietary Supplement
Intervention Name(s)
Control (milk without DHA)
Other Intervention Name(s)
Placebo group
Intervention Description
mothers consuming placebo product and their neonates
Primary Outcome Measure Information:
Title
Change of Visual Development of newborn
Description
Visual Evoked Potentials
Time Frame
Change from Baseline at 12 months of life
Secondary Outcome Measure Information:
Title
Change of bone turnover biomarkers in blood samples during supplementation
Description
indicators of Bone turnover in the mother and their child
Time Frame
Change from Baseline after supplementation (2,5 months)
Title
Change of oxidative stress parameters in mother milk samples during supplementation
Description
oxidative stress parameters (indicators of oxidative stress to lipids and proteins and antioxidant defense)
Time Frame
Change from Baseline after supplementation (2,5 months)
Title
Motor and cognitive development of newborn
Description
Bayleys test
Time Frame
12 months

10. Eligibility

Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Consent mother with normal gestation. Exclusion Criteria: Risk factors during gestation. Lactose intolerance systemic illness. Kwashiorkor. Metabolic illness. Foetal pathologies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio J Ochoa
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julio J. Ochoa
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25988553
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.
Results Reference
derived

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Effect of Mother DHA Supplementation on Term Newborn.

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