NCT01947426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
Last Updated

September 20, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

September 4, 2013

Last Update Submit

September 17, 2013

Conditions

Oxidative StressInflammationInfant Development

Keywords

DHA, term neonates, mother milk

Outcome Measures

Primary Outcomes (1)

  • Change of Visual Development of newborn

    Visual Evoked Potentials

    Change from Baseline at 12 months of life

Secondary Outcomes (3)

  • Change of bone turnover biomarkers in blood samples during supplementation

    Change from Baseline after supplementation (2,5 months)

  • Change of oxidative stress parameters in mother milk samples during supplementation

    Change from Baseline after supplementation (2,5 months)

  • Motor and cognitive development of newborn

    12 months

Study Arms (2)

DHA supplementation

EXPERIMENTAL

mother consuming 400 mg/day of DHA and tehir neonates

Dietary Supplement: DHA Supplementation

Control (milk without DHA)

PLACEBO COMPARATOR

Mothers comsuming placebo and their neonates

Dietary Supplement: Control (milk without DHA)

Interventions

DHA SupplementationDIETARY_SUPPLEMENT

mothers consuming 400 mg of DHA/day and their neonates

Also known as: Docosahexaenoic acid
DHA supplementation
Control (milk without DHA)DIETARY_SUPPLEMENT

mothers consuming placebo product and their neonates

Also known as: Placebo group
Control (milk without DHA)

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Consent
  • mother with normal gestation.

You may not qualify if:

  • Risk factors during gestation.
  • Lactose intolerance
  • systemic illness.
  • Kwashiorkor.
  • Metabolic illness.
  • Foetal pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julio J. Ochoa

Granada, Granada, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 25988553DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Docosahexaenoic AcidsMilk

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Julio J Ochoa

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Julio J. Ochoa, Professor, PhD

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 20, 2013

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

September 20, 2013

Record last verified: 2013-09

Locations

ES(1)