Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

DHA Supplementation for Lactating Mothers (DHA-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732874
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

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 Dutch State Mines (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 or disease Intervention/treatment Phase
Docosohexaenoic Acid Supplementation of Mothers to Drug: Expecta 200 mg Drug: Expecta 1 gram Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis
Actual Study Start Date : May 2013
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : July 16, 2018

Arm Intervention/treatment
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.
Other Name: Prenatal Dietary Supplement

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.
Other Name: Prenatal Dietary Supplement




Primary Outcome Measures :
  1. Infant Serum Soluble Receptor for AGE (sRAGE) Levels at 4 Weeks From Baseline From Mothers Supplemented With 200 or 1000 mg/kg Per Day of DHA [ Time Frame: value at week 4 ]
    The study was powered to detect differences in sRAGE levels in infant serum samples at 4 weeks of age from mothers supplemented with 200 or 1000 mg/kg per day of DHA. Serum Soluble Receptor for AGE (sRAGE) levels range from 7300-100 pg/mL where the higher number means a worse outcome.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732874


Locations
Layout table for location information
United States, Ohio
Cincinnati University Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Layout table for investigator information
Principal Investigator: Ardythe Morrow, PhD University of Cincinnati
Principal Investigator: Henry Akinbi, MD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Publications of Results:
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01732874    
Other Study ID Numbers: 2012-0329
First Posted: November 26, 2012    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: October 2018
Keywords provided by Children's Hospital Medical Center, Cincinnati:
DHA
Preterm infant
Inflammation
Growth
Developement