DHA Supplementation for Lactating Mothers

Phase 1

Completed

• Conditions: Docosohexaenoic Acid Supplementation of Mothers to
• Interventions: Drug: Expecta 1 gram; Drug: Expecta 200 mg

• Registration Number: NCT01732874
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-26
• Study Start: 2013-05
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Status Verified: 2018-10
• Results First Submitted: 2020-09-10
• Results First Submitted QC: 2020-12-08
• Last Update Submitted: 2020-12-08
• Results First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expecta 1 Gram	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.
Expecta 200 mg	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cincinnati University Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States