DHA-1: DHA Supplementation for Lactating Mothers

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01732874
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 62.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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 1, 2013
• Actual Primary Completion Date: Jul 16, 2018
• Actual Study Completion Date: Jul 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Prenatal Dietary Supplement
Other: 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 Names: Prenatal Dietary Supplement

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati University Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

• Principal Investigator: Ardythe Morrow, PhD, University of Cincinnati
• Principal Investigator: Henry Akinbi, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 12, 2013

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT01732874
• Other Study ID Numbers: 2012-0329
• First Posted: Nov 26, 2012
• Last Update Posted: Jan 5, 2021
• Last Verified: Oct 1, 2018

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

Study Results

Participant Flow

Recruitment Details	Mothers recruited at The University of Cincinnati with pregnancy < 28 weeks and no congenital anomalies

Arm/Group Title	Expecta 200 mg	Expecta 1 Gram
Arm/Group Description	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. 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.	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. 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.
Period Title: Overall Study
STARTED	16	11
COMPLETED	8	8
NOT COMPLETED	8	3

Baseline Characteristics

Arm/Group Title	Expecta 200 mg	Expecta 1 Gram	Total
Arm/Group Description	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. 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.	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. 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.	Total of all reporting groups
Overall Participants	16	11	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	16 100%	11 100%	27 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	16 100%	11 100%	27 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	0 0%	1 3.7%
Not Hispanic or Latino	15 93.8%	11 100%	26 96.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 18.8%	4 36.4%	7 25.9%
White	10 62.5%	6 54.5%	16 59.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 18.8%	1 9.1%	4 14.8%
Baseline Infant Serum Soluble Receptor for AGE (sRAGE) levels (pg/ml) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [pg/ml]	746	5336	3041

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	value at week 4

Outcome Measure Data

Analysis Population Description

Lactating mothers of pre-mature infants

Arm/Group Title	Expecta 200 mg	Expecta 1 Gram
Arm/Group Description	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. 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.	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. 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.
Measure Participants	16	11
Median (Inter-Quartile Range) [pg/mL]	900	1127

Adverse Events

Time Frame	baseline to 4 weeks
Arm/Group Title	Expecta 200 mg		Expecta 1 Gram
Arm/Group Description	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. 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.		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. 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.
All Cause Mortality
	Expecta 200 mg		Expecta 1 Gram
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)
Serious Adverse Events
	Expecta 200 mg		Expecta 1 Gram
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Expecta 200 mg		Expecta 1 Gram
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/11 (0%)

Limitations/Caveats

The small sample size prevented the use of Repeated Measures Analyses, which would have given the study more power to detect differences and the ability to statistically control for any of the infant morbidities.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.