Effect of Docosahexaenoic Acid (DHA)-Enriched Human Milk in Premature Newborns

Premature Clinical Trial

— DHARMA  

Official title:

Improvement of Polyunsaturated Fatty Acids Status in Premature Newborns Following Docosahexaenoic Acid Enrichment of Human Milk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062373
• Other study ID #: C08-20
• Secondary ID: 2009-A00006-51
• Status: Terminated
• Phase: N/A
• First received: February 3, 2010
• Last updated: September 26, 2012
• Start date: February 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Several recent publications showed a reduction in the level of DHA and/or an increase in the arachidonic acid (AA)/DHA ratio in the milk of mother. We hypothesized that the polyunsaturated fatty acid (PUFA) status of the premature newborn fed mother's milk is unbalanced because the content of DHA of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of DHA and balanced AA/DHA ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. We will study the benefits of DHA supplements (TG-DHA versus GPL-DHA) of mothers in PUGA status improvement in their premature newborn consecutive to DHA enrichment and balanced AA/DHA ratio of human milk. GPL-DHA should be more effective than TG-DHA by protecting both n-3 and n-6 fatty acids pathways.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• Childbirth between 34 and 35 GA

• Breast-feeding

• Caucasian

• Affiliation to social security

• Obtained consent from mother, and parents for the child

• Mother with balanced diet

• No allergy to eggs

• Single pregnancy

Exclusion Criteria:

• Allergy to egg

• Unbalanced diet

• Diabetes

• Known digestive disease

• Counter-indication with breast-feeding

• Cigarettes (more than 5 per day)

• Alcoholism (daily consumption of alcohol)

• Multiple pregnancy

Study Design

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

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

Dietary Supplement:
• Supplementation of lactating mothers who has delivered prematurely with DHA
Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by TG-DHA from Decola (products from Martek) (two soft capsules per day)
• Supplementation of lactating mothers who has delivered prematurely with DHA
Supplementation in DHA will be conducted for 1 month at the dose of 200 mg DHA per day provided by GPL-DHA from ASL (10 g per day) (two soft capsules per day)

Locations

Country	Name	City	State
France	Service de Médecine néonatale, Hôpital de la Conception	Marseille Cedex 05

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To improve PUFA status in premature newborns		30 days	Yes
Secondary	PUFA in human milk (HM) and mothers		6 months	Yes
Secondary	Impact on HM bioactives		6 months	Yes
Secondary	Change in inflammation and oxydative stress		6 months	Yes
Secondary	Genes expression in newborns		6 months	Yes
Secondary	Link between mothers genetics and HM DHA level		6 months	Yes
Secondary	Newborn survey at 6 month-old		6 months	Yes