Trial record 1 of 7 for:    prenatal dha
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Effects of Prenatal DHA Supplements on Infant Development

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Dr. Usha Ramakrishnan, Emory University
ClinicalTrials.gov Identifier:
NCT00646360
First received: March 25, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

Our research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, we will assess the effect of docosahexanoic acid (DHA) supplementation during pregnancy on infant growth and development through a randomized controlled intervention trial in Cuernavaca, Mexico. This is a collaborative effort between the Rollins School of Public Health, Emory University, the Instituto Nacional de Salud Publica (INSP) and the Instituto Mexicano del Seguro Social (IMSS), Cuernavaca, Mexico. Pregnant women attending the IMSS General Hospital I are recruited between 18-22 wks gestation and assigned randomly to receive either DHA (400 mg) or a placebo daily until delivery. The main study outcomes include a) birth outcomes: birth size, gestational age, cord blood levels of DHA and neurodevelopment b) maternal blood and breast milk DHA levels at 1 and 3 mo post-partum) c) postnatal growth and development during the first 5 years of age and d) infant DHA status at 3, 12 and 18 mo. All data collection is carried out at the study headquarters (IMSS) except for home environment that is assessed during home visits. Physical growth (length, weight, and head circumference) and infant and child development (visual and auditory evoked potentials, visual attention, Bayley scales of infant development, McCarthy child development score, Hearts and Flowers stroop test, and other computerized child development tests) are measured at birth, 1, 3, 6, 9, 12, 18, 24, 36 mo and at 4 and 5 years of age by trained workers. Data are also obtained on socioeconomic status, obstetric history, maternal diet, anthropometry and intelligence, quality of home environment and infant feeding practices. Data analysis will include group comparisons (intent-to-treat) after ensuring effectiveness of randomization, and structural equation modeling to examine the various pathways by which DHA supplementation during pregnancy affects child growth and development. The findings of this project will contribute significantly to our understanding of the functional consequences of DHA supplementation during pregnancy.


Condition Intervention Phase
Pregnancy
Dietary Supplement: DHA
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Prenatal DHA Supplements on Infant Development

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Birth size and gestational age [ Time Frame: Birth ] [ Designated as safety issue: No ]
  • Infant growth and development in the first 5 years of life [ Time Frame: first 5 years of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immune function and morbidity [ Time Frame: first 6 mo of life ] [ Designated as safety issue: No ]

Enrollment: 1094
Study Start Date: February 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Docosahexonic acid (400 mg/day)
Dietary Supplement: DHA
400 mg/d of docosahexanoic acid (DHA) during pregnancy
Other Name: Martek Algal DHA
Placebo Comparator: 2 Dietary Supplement: Placebo
2 tablets daily during pregnancy
Other Name: Specially formulated by Martek Biosciences

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-22 weeks pregnant (based on last menstrual period)
  • 18 - 35 years old
  • Resident of Cuernavaca who intends to deliver at the IMSS General Hospital I and remain in the area for the 2 years following recruitment
  • Intends to predominantly breastfeed infant until 3 months of age
  • Agrees to participate with informed consent

Exclusion criteria

  • High risk pregnancy: If documented in the clinical record at recruitment and will include history and prevalence of abruptio placentae, any serious bleeding episode in the current pregnancy, gestational diabetes, pregnancy induced hypertension, maternal toxoplasmosis infection during pregnancy, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use.
  • Lipid metabolism (hyperlipidemia) and/or absorption disorders
  • Regular intake of fish oil or DHA supplements during pregnancy
  • Chronic use of medication for illnesses like epilepsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646360

Locations
Mexico
IMSS General Hospital I
Cuernavaca, Morelos, Mexico
Sponsors and Collaborators
Emory University
Instituto Nacional de Salud Publica, Mexico
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Usha Ramakrishnan, Ph.D. Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Usha Ramakrishnan, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00646360     History of Changes
Other Study ID Numbers: IRB00024976, HD43099
Study First Received: March 25, 2008
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
birth size, gestational age, development, child growth,
prenatal nutrition, DHA

ClinicalTrials.gov processed this record on October 02, 2014