DHA-1 for Lactating Mothers

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01732874
First received: October 31, 2012
Last updated: September 17, 2014
Last verified: May 2014
  Purpose

The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. Our current intravenous (IV) fats do not contain the long chain fatty acids and different milk sources have different compositions. We would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (DHA- Martek Biosciences, now known as DSM Nutritional Lipid) The DHA supplement is available over the counter.

The information learned from this research study may benefit other mothers and babies in the future. The information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.


Condition Intervention Phase
Level/Amount of DHA in Mothers Breast Milk and Blood.
Drug: Expecta 200 mg
Drug: Expecta 1 gram
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Level/amount of DHA in mothers breast milk and blood. [ Time Frame: change in DHA level from baseline to 8 wks. ] [ Designated as safety issue: No ]
    The objective of this project is to improve preterm infant intake of DHA that approximate the levels obtained by fetal accretion during the third trimester of pregnancy and determine if there are functional relationships to inflammation, growth, and development


Secondary Outcome Measures:
  • Cytokines [ Time Frame: change in DHA levels from baseline to 8 wks ] [ Designated as safety issue: No ]
    Higher intakes of dietary DHA will decrease expression of pro-inflammatory cytokines and increase expression of anti-inflammatory cytokines in the plasma and milk samples of breast feeding mother - infant dyads through the alteration of sRAGE signaling.


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Expecta 200 mg
Breastfeeding mothers of pre-mature infants randomly assigned to 200 mg Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Drug: Expecta 200 mg
Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
Expecta 1 Gram
Breastfeeding mothers of pre-mature infants randomly assigned to one Gram of Expecta to be taken orally once a day. Expecta to be taken for approximately 8 weeks post-partum or a shorter time if infant is discharged sooner from NICU.
Drug: Expecta 1 gram
Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.

Detailed Description:

We designed a prospective, randomized trial to test the hypotheses that DHA supplementation to human milk providers will increase DHA concentration in milk and infant blood levels; and that infants receiving milk from DHA-supplemented providers will be receiving a more appropriate enteral intake to better mimic intrauterine accretion. In addition, we hypothesize that pro-inflammatory cytokines will be reduced in the mothers and infants receiving the higher DHA diet.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Lactating mothers at Cincinnati University Hospital with infants born at < 29 weeks gestation.

-

Exclusion Criteria:• the presence of congenital anomalies (trisomy 13, 18, 21, urethral, gastrointestinal and cardiac defects) that affect the standard course of care.

  • mother's <18 and
  • mothers with known allergy to algeal source
  • mothers with history of bleeding disorders or taking any other medication that may increase the risk of bleeding
  • infants with bleeding disorders or receiving any other medication that may increase the risk of bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732874

Contacts
Contact: Ardythe Morrow, PhD (513) 636-7584 ardythe.morrow@cchmc.org
Contact: Jeanne Kleiman, BS, CLC, ALC (513) 636-9719 Jeanne.Kleiman@cchmc.org

Locations
United States, Ohio
Cincinnati University Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Ardythe Morrow, PhD    (513) 636-7584    Ardythe.morrow@cchmc.org   
Contact: Jeanne Kleiman, BS, CLC, ALC, CCRP    (513) 636-9719    Jeanne.Kleiman@cchmc.org   
Principal Investigator: Ardythe Morrow, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Ardythe Morrow, PhD Cincinnati Children's Hosptial Medical Center
Principal Investigator: Henry Akinbi, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01732874     History of Changes
Other Study ID Numbers: 2012-0329
Study First Received: October 31, 2012
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Medical Center, Cincinnati:
DHA
Preterm infant
Inflammation
Growth
Developement

ClinicalTrials.gov processed this record on September 29, 2014