DHA-1 for Lactating Mothers
This trial is active, not recruiting.
|Condition||amount of dha in mothers breast milk and blood.|
|Treatments||expecta 200 mg, expecta 1 gram|
|Phase||phase 1/phase 2|
|Sponsor||Children's Hospital Medical Center, Cincinnati|
|Start date||November 2012|
|End date||December 2016|
|Trial size||20 participants|
|Trial identifier||NCT01732874, 2012-0329|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Level/amount of DHA in mothers breast milk and blood.
time frame: change in DHA level from baseline to 8 wks.
time frame: change in DHA levels from baseline to 8 wks
Female participants up to 45 years old.
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
|Official title||Docosahexaenoic Acid Supplementation of Mothers to Improve Preterm Infant Nutrition and Immune Homeostasis|
|Principal investigator||Ardythe Morrow, PhD|
|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.|
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