Effect of Mother DHA Supplementation on Premature Newborn.

Oxidative Stress Clinical Trial

Official title:

Multidisciplinary Study of the Effect of the Mother suplementación During the Lactation With High Doses of DHA on Diverse Aspects Related to the Development of the Premature Newborn in the First Year of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940640
• Other study ID #: AGL2011-24014
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 3, 2013
• Last updated: November 30, 2015
• Start date: January 2012
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Experimental design: We will establish two groups of premature newborn children (<34 weeks) (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). In addition, all the groups will be underwent to a nutritional surveillance (a follow-up of 48 hours and a questionnaire of frequency of consumption) and will be given nutritionally-balanced diets, insisting especially in the suitable consumption of fish (4 portions/week). Blood samples will be obtained in all the groups at the birth moment, at the week 40 of gestational age corrected in the groups of premature babies and at the end of the lactation in all the groups (minimum 3 months).We will obtain samples of mother´s milk (colostrum, transition and mature milk). In these samples we will study bone turnover biomarkers, pro - and anti-inflammatory citoquines and markers of aggression oxidative damage. In addition, we will perform psychomotor and visual development tests in the newborn children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• Oxidative Stress
• Premature Birth

Intervention

Dietary Supplement:
• DHA
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).
• control
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).

Locations

Country	Name	City	State
Spain	Hospital San Cecilio	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood and milk samples	Assessment of oxidative stress	at delivery	No
Secondary	Blood	inflammation and bone development parameters	at delivery	No