PregnancyNCT00646360
Effects of Prenatal DHA Supplements on Infant Development
A study testing DHA in people with Pregnancy, run by Emory University at 1 site in Mexico.
Trial summary
This research study research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team will assess the effect of docosahexanoic acid (DHA) supplementation during pregnancy on infant growth and development through a randomized controlled intervention trial in… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,094 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2005to 16 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This research study research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team 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 weeks 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 months post-partum, c) postnatal growth and development during the first 5 years of age and d) infant DHA status at 3, 12 and 18 months.
Read the detailed description
This research study is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team 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 months 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.
- Conditions
- Pregnancy
- Being tested
- DHA, Placebo
- Keywords
- birth size, gestational age, development, child growth,, prenatal nutrition, DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHADietary supplement
Also called Martek Algal DHA
400 mg/d of docosahexanoic acid (DHA) during pregnancy
PlaceboDietary supplement
Also called Specially formulated by Martek Biosciences
2 tablets daily during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| DHA arm | Experimental | Docosahexonic acid (DHA) (400 mg/day). 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. Receives: Dietary Supplement: DHA |
| Placebo arm | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth size
Birth size will be determined by measuring the newborn, a baby's length is measured from the top of their head to the bottom of one of their heels.
Measured: Birth
Gestational age
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the current date.
Measured: Birth
Changes in visual evoked potentials
Visual evoked potential (VEP) is an electrical signal emanated from the brain while a visual stimulus is presented to the subject in a time locked manner. The VEP can be used as a diagnostic tool to detect ocular diseases in patients with visually impaired. VEP response can also be used to detect eye diseases like glaucoma, diabetic retinopathy, multiple sclerosis, ocular hypertension, loss of peripheral (side) vision, macular degeneration and color blindness.
Measured: 3 and 6 months of age
Changes in infant weight
Infant weight is measured in kilograms (kg) and weight is measured in the hospital and at all check-ups.
Measured: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Changes in infant height
Infants will be measured in the hospital and at all check-ups. Height is measured in centimeters (cm).
Measured: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Changes In infant head circumference
Head circumference or OFC [occipital frontal circumference] is measured over the most prominent part on the back of the head (occiput) and just above the eyebrows (supraorbital ridges). This can be translated to mean the largest circumference of the head. Head circumference is measured in centimeters (cm).
Measured: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Changes in auditory evoked potentials
A brainstem auditory evoked response (BAER) test measures how the brain processes the sounds a person hears. The BAER test records the subject's brainwaves in response to clicks or other audio tones that are played for them.
Measured: 1 and 3 months of age
Changes in child development score
The Bayley Scales of Infant Development -II are used to assess child development during the first two years of life while The McCarthy Scales of Children's Abilities (MSCA) is a psychological instrument for young children that measures cognitive ability in six domain areas: Verbal, Perceptual-Performance, Quantitative, General Cognitive, Memory, and Motor at age 5 y.
Measured: 1, 1.5 and 5 years of age
Changes in Hearts and Flowers Stroop Test
This tests working memory, response inhibition, and task switching/cognitive flexibility . The task requires participants to press a response button that is either on the same side (congruent) or opposite side (incongruent) of an image. When children see an image of a heart, they are instructed to press the corresponding directional arrow button on a keyboard. When children see an image of a flower, they are instructed to press the opposite directional arrow button on the keyboard . The task consists of three separate levels that contain only congruent trials (12 trials total), only incongruent trials (12 trials total), and mixed congruent and incongruent trials respectively (33 trials total). Images are presented on a computer monitor. Before both the congruent and incongruent trial blocks, a training period is administered which consists of 5 trials. The child is unable to advance to the next question until they respond correctly.
Measured: 5 years of age
Secondary outcomes (3)
Changes Immune function
Measured: first 6 months of life
Changes in Morbidity
Changes in morbidity (health) factors will be assessed.
Measured: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Cognitive outcomes at age 7 years of age
The cognitive intelligence test WAIS-IV offers compound scores that reflect the intellectual functioning of 4 cognitive areas (verbal understanding, perceptive reasoning, working memory and processing speed). It also offers a compound score that reflects intellectual aptitude in general (Intelligence quotient).
Measured: At 7 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startFeb 2005
- Primary completion3 Jan 2013
- Study completion16 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico, Instituto Mexicano del Seguro Social, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Usha Ramakrishnan, Emory University
- Investigators
- Usha Ramakrishnan, Ph.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646360
- Sponsor's protocol ID
- IRB00024976
- Other IDs
- 5R01HD043099, 5R03HD087606
- Status last verified
- Jun 2022
- First submitted
- 25 Mar 2008
- Last updated
- 7 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wimalasena ST, Ramirez-Silva CI, Gonzalez Casanova I, Stein AD, Sun YV, Rivera JA, Demmelmair H, Koletzko B, Ramakrishnan U. Effects of prenatal docosahexaenoic acid supplementation on offspring cardiometabolic health at 11 years differs by maternal single nucleotide polymorphism rs174602: follow-up of a randomized controlled trial in Mexico. Am J Clin Nutr. 2023 Dec;118(6):1123-1132. doi: 10.1016/j.ajcnut.2023.10.005. Epub 2023 Oct 14.
PubMed 37839707Gonzalez Casanova I, Schoen M, Tandon S, Stein AD, Barraza Villarreal A, DiGirolamo AM, Demmelmair H, Ramirez Silva I, Feregrino RG, Rzehak P, Stevenson I, Standl M, Schnaas L, Romieu I, Koletzko B, Ramakrishnan U. Maternal FADS2 single nucleotide polymorphism modified the impact of prenatal docosahexaenoic acid (DHA) supplementation on child neurodevelopment at 5 years: Follow-up of a randomized clinical trial. Clin Nutr. 2021 Oct;40(10):5339-5345. doi: 10.1016/j.clnu.2021.08.026. Epub 2021 Sep 11.
PubMed 34543890Tandon S, Gonzalez-Casanova I, Barraza-Villarreal A, Romieu I, Demmelmair H, Jones DP, Koletzko B, Stein AD, Ramakrishnan U. Infant Metabolome in Relation to Prenatal DHA Supplementation and Maternal Single-Nucleotide Polymorphism rs174602: Secondary Analysis of a Randomized Controlled Trial in Mexico. J Nutr. 2021 Nov 2;151(11):3339-3349. doi: 10.1093/jn/nxab276.
PubMed 34494106Barrios PL, Garcia-Feregrino R, Rivera JA, Barraza-Villarreal A, Hernandez-Cadena L, Romieu I, Gonzalez-Casanova I, Ramakrishnan U, Hoffman DJ. Height Trajectory During Early Childhood Is Inversely Associated with Fat Mass in Later Childhood in Mexican Boys. J Nutr. 2019 Nov 1;149(11):2011-2019. doi: 10.1093/jn/nxz157.
PubMed 31334762Gonzalez-Casanova I, Stein AD, Barraza-Villarreal A, Feregrino RG, DiGirolamo A, Hernandez-Cadena L, Rivera JA, Romieu I, Ramakrishnan U. Prenatal exposure to environmental pollutants and child development trajectories through 7 years. Int J Hyg Environ Health. 2018 May;221(4):616-622. doi: 10.1016/j.ijheh.2018.04.004. Epub 2018 Apr 22.
PubMed 29699913Gutierrez-Delgado RI, Barraza-Villarreal A, Escamilla-Nunez C, Hernandez-Cadena L, Garcia-Feregrino R, Shackleton C, Ramakrishnan U, Sly PD, Romieu I. Effect of omega-3 fatty acids supplementation during pregnancy on lung function in preschoolers: a clinical trial. J Asthma. 2019 Mar;56(3):296-302. doi: 10.1080/02770903.2018.1452934. Epub 2018 Apr 4.
PubMed 29617210Gutierrez-Gomez Y, Stein AD, Ramakrishnan U, Barraza-Villarreal A, Moreno-Macias H, Aguilar-Salinas C, Romieu I, Rivera JA. Prenatal Docosahexaenoic Acid Supplementation Does Not Affect Nonfasting Serum Lipid and Glucose Concentrations of Offspring at 4 Years of Age in a Follow-Up of a Randomized Controlled Clinical Trial in Mexico. J Nutr. 2017 Feb;147(2):242-247. doi: 10.3945/jn.116.238329. Epub 2016 Dec 21.
PubMed 28003539Ramakrishnan U, Gonzalez-Casanova I, Schnaas L, DiGirolamo A, Quezada AD, Pallo BC, Hao W, Neufeld LM, Rivera JA, Stein AD, Martorell R. Prenatal supplementation with DHA improves attention at 5 y of age: a randomized controlled trial. Am J Clin Nutr. 2016 Oct;104(4):1075-1082. doi: 10.3945/ajcn.114.101071. Epub 2016 Sep 7.
PubMed 27604770Gonzalez-Casanova I, Rzehak P, Stein AD, Garcia Feregrino R, Rivera Dommarco JA, Barraza-Villarreal A, Demmelmair H, Romieu I, Villalpando S, Martorell R, Koletzko B, Ramakrishnan U. Maternal single nucleotide polymorphisms in the fatty acid desaturase 1 and 2 coding regions modify the impact of prenatal supplementation with DHA on birth weight. Am J Clin Nutr. 2016 Apr;103(4):1171-8. doi: 10.3945/ajcn.115.121244. Epub 2016 Feb 24.
PubMed 26912491Ramakrishnan U, Stinger A, DiGirolamo AM, Martorell R, Neufeld LM, Rivera JA, Schnaas L, Stein AD, Wang M. Prenatal Docosahexaenoic Acid Supplementation and Offspring Development at 18 Months: Randomized Controlled Trial. PLoS One. 2015 Aug 11;10(8):e0120065. doi: 10.1371/journal.pone.0120065. eCollection 2015.
PubMed 26262896Gonzalez-Casanova I, Stein AD, Hao W, Garcia-Feregrino R, Barraza-Villarreal A, Romieu I, Rivera JA, Martorell R, Ramakrishnan U. Prenatal Supplementation with Docosahexaenoic Acid Has No Effect on Growth through 60 Months of Age. J Nutr. 2015 Jun;145(6):1330-4. doi: 10.3945/jn.114.203570. Epub 2015 Apr 29.
PubMed 25926416Escamilla-Nunez MC, Barraza-Villarreal A, Hernandez-Cadena L, Navarro-Olivos E, Sly PD, Romieu I. Omega-3 fatty acid supplementation during pregnancy and respiratory symptoms in children. Chest. 2014 Aug;146(2):373-382. doi: 10.1378/chest.13-1432.
PubMed 24626819Hernandez E, Barraza-Villarreal A, Escamilla-Nunez MC, Hernandez-Cadena L, Sly PD, Neufeld LM, Ramakishnan U, Romieu I. Prenatal determinants of cord blood total immunoglobulin E levels in Mexican newborns. Allergy Asthma Proc. 2013 Sep-Oct;34(5):e27-34. doi: 10.2500/aap.2013.34.3688.
PubMed 23998234Stein AD, Wang M, Rivera JA, Martorell R, Ramakrishnan U. Auditory- and visual-evoked potentials in Mexican infants are not affected by maternal supplementation with 400 mg/d docosahexaenoic acid in the second half of pregnancy. J Nutr. 2012 Aug;142(8):1577-81. doi: 10.3945/jn.112.162461. Epub 2012 Jun 27.
PubMed 22739364Imhoff-Kunsch B, Stein AD, Martorell R, Parra-Cabrera S, Romieu I, Ramakrishnan U. Prenatal docosahexaenoic acid supplementation and infant morbidity: randomized controlled trial. Pediatrics. 2011 Sep;128(3):e505-12. doi: 10.1542/peds.2010-1386. Epub 2011 Aug 1.
PubMed 21807696
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prenatal DHA Supplements on Infant Development
- ClinicalTrials.gov ID
- NCT00646360
- Acronym / sponsor ID
- IRB00024976
- Conditions
- Pregnancy
- Keywords
- birth size, gestational age, development, child growth,, prenatal nutrition, DHA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,094 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Instituto Nacional de Salud Publica, Mexico, Instituto Mexicano del Seguro Social, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Feb 2005 (actual)
- Primary completion
- 3 Jan 2013 (actual)
- Study completion
- 16 Aug 2014 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study research is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team 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 weeks 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 months post-partum, c) postnatal growth and development during the first 5 years of age and d) infant DHA status at 3, 12 and 18 months.
Detailed description
This research study is about the significance of polyunsaturated fatty acids (PUFAs) for human development. Specifically, the study team 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 months 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA arm | Experimental | Dietary Supplement: DHADocosahexonic acid (DHA) (400 mg/day). 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. |
| Placebo arm | Placebo comparator | Dietary Supplement: PlaceboPregnant 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHAAlso: Martek Algal DHA400 mg/d of docosahexanoic acid (DHA) during pregnancy | Dietary supplement | DHA arm |
| PlaceboAlso: Specially formulated by Martek Biosciences2 tablets daily during pregnancy | Dietary supplement | Placebo arm |
Primary outcome
Birth size
Time frame: Birth
Birth size will be determined by measuring the newborn, a baby's length is measured from the top of their head to the bottom of one of their heels.
Gestational age
Time frame: Birth
Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the current date.
Changes in visual evoked potentials
Time frame: 3 and 6 months of age
Visual evoked potential (VEP) is an electrical signal emanated from the brain while a visual stimulus is presented to the subject in a time locked manner. The VEP can be used as a diagnostic tool to detect ocular diseases in patients with visually impaired. VEP response can also be used to detect eye diseases like glaucoma, diabetic retinopathy, multiple sclerosis, ocular hypertension, loss of peripheral (side) vision, macular degeneration and color blindness.
Changes in infant weight
Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Infant weight is measured in kilograms (kg) and weight is measured in the hospital and at all check-ups.
Changes in infant height
Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Infants will be measured in the hospital and at all check-ups. Height is measured in centimeters (cm).
Changes In infant head circumference
Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Head circumference or OFC [occipital frontal circumference] is measured over the most prominent part on the back of the head (occiput) and just above the eyebrows (supraorbital ridges). This can be translated to mean the largest circumference of the head. Head circumference is measured in centimeters (cm).
Changes in auditory evoked potentials
Time frame: 1 and 3 months of age
A brainstem auditory evoked response (BAER) test measures how the brain processes the sounds a person hears. The BAER test records the subject's brainwaves in response to clicks or other audio tones that are played for them.
Changes in child development score
Time frame: 1, 1.5 and 5 years of age
The Bayley Scales of Infant Development -II are used to assess child development during the first two years of life while The McCarthy Scales of Children's Abilities (MSCA) is a psychological instrument for young children that measures cognitive ability in six domain areas: Verbal, Perceptual-Performance, Quantitative, General Cognitive, Memory, and Motor at age 5 y.
Changes in Hearts and Flowers Stroop Test
Time frame: 5 years of age
This tests working memory, response inhibition, and task switching/cognitive flexibility . The task requires participants to press a response button that is either on the same side (congruent) or opposite side (incongruent) of an image. When children see an image of a heart, they are instructed to press the corresponding directional arrow button on a keyboard. When children see an image of a flower, they are instructed to press the opposite directional arrow button on the keyboard . The task consists of three separate levels that contain only congruent trials (12 trials total), only incongruent trials (12 trials total), and mixed congruent and incongruent trials respectively (33 trials total). Images are presented on a computer monitor. Before both the congruent and incongruent trial blocks, a training period is administered which consists of 5 trials. The child is unable to advance to the next question until they respond correctly.
3 secondary outcomes
Changes Immune function
Time frame: first 6 months of life
Changes in Morbidity
Time frame: Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age
Cognitive outcomes at age 7 years of age
Time frame: At 7 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Derived from this study: PubMed 37839707Wimalasena ST, Ramirez-Silva CI, Gonzalez Casanova I, Stein AD, Sun YV, Rivera JA, Demmelmair H, Koletzko B, Ramakrishnan U. Effects of prenatal docosahexaenoic acid supplementation on offspring cardiometabolic health at 11 years differs by maternal single nucleotide polymorphism rs174602: follow-up of a randomized controlled trial in Mexico. Am J Clin Nutr. 2023 Dec;118(6):1123-1132. doi: 10.1016/j.ajcnut.2023.10.005. Epub 2023 Oct 14.
- Derived from this study: PubMed 34543890Gonzalez Casanova I, Schoen M, Tandon S, Stein AD, Barraza Villarreal A, DiGirolamo AM, Demmelmair H, Ramirez Silva I, Feregrino RG, Rzehak P, Stevenson I, Standl M, Schnaas L, Romieu I, Koletzko B, Ramakrishnan U. Maternal FADS2 single nucleotide polymorphism modified the impact of prenatal docosahexaenoic acid (DHA) supplementation on child neurodevelopment at 5 years: Follow-up of a randomized clinical trial. Clin Nutr. 2021 Oct;40(10):5339-5345. doi: 10.1016/j.clnu.2021.08.026. Epub 2021 Sep 11.
- Derived from this study: PubMed 34494106Tandon S, Gonzalez-Casanova I, Barraza-Villarreal A, Romieu I, Demmelmair H, Jones DP, Koletzko B, Stein AD, Ramakrishnan U. Infant Metabolome in Relation to Prenatal DHA Supplementation and Maternal Single-Nucleotide Polymorphism rs174602: Secondary Analysis of a Randomized Controlled Trial in Mexico. J Nutr. 2021 Nov 2;151(11):3339-3349. doi: 10.1093/jn/nxab276.
- Derived from this study: PubMed 31334762Barrios PL, Garcia-Feregrino R, Rivera JA, Barraza-Villarreal A, Hernandez-Cadena L, Romieu I, Gonzalez-Casanova I, Ramakrishnan U, Hoffman DJ. Height Trajectory During Early Childhood Is Inversely Associated with Fat Mass in Later Childhood in Mexican Boys. J Nutr. 2019 Nov 1;149(11):2011-2019. doi: 10.1093/jn/nxz157.
- Derived from this study: PubMed 29699913Gonzalez-Casanova I, Stein AD, Barraza-Villarreal A, Feregrino RG, DiGirolamo A, Hernandez-Cadena L, Rivera JA, Romieu I, Ramakrishnan U. Prenatal exposure to environmental pollutants and child development trajectories through 7 years. Int J Hyg Environ Health. 2018 May;221(4):616-622. doi: 10.1016/j.ijheh.2018.04.004. Epub 2018 Apr 22.
- Derived from this study: PubMed 29617210Gutierrez-Delgado RI, Barraza-Villarreal A, Escamilla-Nunez C, Hernandez-Cadena L, Garcia-Feregrino R, Shackleton C, Ramakrishnan U, Sly PD, Romieu I. Effect of omega-3 fatty acids supplementation during pregnancy on lung function in preschoolers: a clinical trial. J Asthma. 2019 Mar;56(3):296-302. doi: 10.1080/02770903.2018.1452934. Epub 2018 Apr 4.
- Derived from this study: PubMed 28003539Gutierrez-Gomez Y, Stein AD, Ramakrishnan U, Barraza-Villarreal A, Moreno-Macias H, Aguilar-Salinas C, Romieu I, Rivera JA. Prenatal Docosahexaenoic Acid Supplementation Does Not Affect Nonfasting Serum Lipid and Glucose Concentrations of Offspring at 4 Years of Age in a Follow-Up of a Randomized Controlled Clinical Trial in Mexico. J Nutr. 2017 Feb;147(2):242-247. doi: 10.3945/jn.116.238329. Epub 2016 Dec 21.
- Derived from this study: PubMed 27604770Ramakrishnan U, Gonzalez-Casanova I, Schnaas L, DiGirolamo A, Quezada AD, Pallo BC, Hao W, Neufeld LM, Rivera JA, Stein AD, Martorell R. Prenatal supplementation with DHA improves attention at 5 y of age: a randomized controlled trial. Am J Clin Nutr. 2016 Oct;104(4):1075-1082. doi: 10.3945/ajcn.114.101071. Epub 2016 Sep 7.
- Derived from this study: PubMed 26912491Gonzalez-Casanova I, Rzehak P, Stein AD, Garcia Feregrino R, Rivera Dommarco JA, Barraza-Villarreal A, Demmelmair H, Romieu I, Villalpando S, Martorell R, Koletzko B, Ramakrishnan U. Maternal single nucleotide polymorphisms in the fatty acid desaturase 1 and 2 coding regions modify the impact of prenatal supplementation with DHA on birth weight. Am J Clin Nutr. 2016 Apr;103(4):1171-8. doi: 10.3945/ajcn.115.121244. Epub 2016 Feb 24.
- Derived from this study: PubMed 26262896Ramakrishnan U, Stinger A, DiGirolamo AM, Martorell R, Neufeld LM, Rivera JA, Schnaas L, Stein AD, Wang M. Prenatal Docosahexaenoic Acid Supplementation and Offspring Development at 18 Months: Randomized Controlled Trial. PLoS One. 2015 Aug 11;10(8):e0120065. doi: 10.1371/journal.pone.0120065. eCollection 2015.
- Derived from this study: PubMed 25926416Gonzalez-Casanova I, Stein AD, Hao W, Garcia-Feregrino R, Barraza-Villarreal A, Romieu I, Rivera JA, Martorell R, Ramakrishnan U. Prenatal Supplementation with Docosahexaenoic Acid Has No Effect on Growth through 60 Months of Age. J Nutr. 2015 Jun;145(6):1330-4. doi: 10.3945/jn.114.203570. Epub 2015 Apr 29.
- Derived from this study: PubMed 24626819Escamilla-Nunez MC, Barraza-Villarreal A, Hernandez-Cadena L, Navarro-Olivos E, Sly PD, Romieu I. Omega-3 fatty acid supplementation during pregnancy and respiratory symptoms in children. Chest. 2014 Aug;146(2):373-382. doi: 10.1378/chest.13-1432.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usha Ramakrishnan, Ph.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA in people with Pregnancy, run by Emory University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth size (time frame: Birth). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646360, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022; AzTrials last refreshed its copy on 6 Nov 2026.