Effect of Mother DHA Supplementation on Premature Newborn.

NCT01940640 | Completed Phase 2 DMC

• 1 other identifier: AGL2011-24014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To date, the investigations in the field of the supplementation with DHA in premature babies have been focused on the study of neuronal and visual development, giving place to contradictory and ambiguous results, because they did not consider in many cases important aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise studies have not been performed in the field of the oxidative damage, inflammation and bone development in this population. Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a mother supplementation with high doses of DHA will increase proportionally the levels of this fatty acid in her milk, fact that will allows the premature newborn child receive a major dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and visual development and to take part on the inflammatory process, oxidative damage and its evolution, together with the development or bone mass increase in the premature baby. Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother supplementation during the lactation with high doses of DHA on the development and wellness of the premature newborn children. We try to deepen into the effect on the neuronal and visual development and to study, for the first time, the effect on the oxidative damage, pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.

Conditions

Oxidative Stress

Keywords

neonates, DHA

Outcome Measures

Primary Outcomes (1)

• blood and milk samples

  Assessment of oxidative stress

  at delivery

Secondary Outcomes (1)

• Blood

  at delivery

Study Arms (2)

DHA supplementation

EXPERIMENTAL

mothers consuming 900 mg DHA/day and their neonates.

Dietary Supplement: DHA

Control

ACTIVE COMPARATOR

follow on capsules without probiotics

Dietary Supplement: control

Interventions

DHA DIETARY_SUPPLEMENT

We will establish two groups of premature newborn children (\<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months).

Also known as: Docosahexaenoic acid

DHA supplementation

control DIETARY_SUPPLEMENT

We will establish two groups of premature newborn children (\<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA during the lactation (minimum period of 3 months).

Also known as: Follow on capsules without probiotics

Control

Eligibility Criteria

• Age: 1 Hour - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonate, gestational age 30-34, PAEG (\>P10, \<P95), no pathologies.

You may not qualify if:

• Lactose intolerance, systemic illness, multiple gestation, cromosomopathies, antibacterial therapy.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Hospital San Cecilio

Granada, Granada, 18071, Spain

Location

MeSH Terms

Interventions

Docosahexaenoic Acids

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Julio J Ochoa, Ph.D.

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 12, 2013
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

ES (1)