DHA Supplementation for Lactating Mothers

NCT ID: NCT01732874

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-07-16

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.

Conditions

Docosohexaenoic Acid Supplementation of Mothers to

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: OTHER

Expecta 200 mg

Intervention Type: DRUG

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.

Group Type: OTHER

Expecta 1 gram

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Prenatal Dietary Supplement; Prenatal Dietary Supplement

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

• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ardythe Morrow, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Henry Akinbi, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati University Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

Valentine CJ, Dingess KA, Kleiman J, Morrow AL, Rogers LK. A Randomized Trial of Maternal Docosahexaenoic Acid Supplementation to Reduce Inflammation in Extremely Preterm Infants. J Pediatr Gastroenterol Nutr. 2019 Sep;69(3):388-392. doi: 10.1097/MPG.0000000000002375.

Reference Type: RESULT

PMID: 31058771 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012-0329

Identifier Type: -

Identifier Source: org_study_id