Phase 2 N=27 Randomized Triple-blind Basic Science

DHA Supplementation for Lactating Mothers

Docosohexaenoic Acid Supplementation of Mothers to

Bottom Line

View on ClinicalTrials.gov: NCT01732874 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: 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 — 900; 1127 pg/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Expecta 200 mg (Drug); Expecta 1 gram (Drug)
Age: Pediatric, Adult
Sex: Female
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	900; 1127	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01732874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.