Effects of Prenatal DHA Supplements on Infant Development
NCT00646360, Not applicable, Completed, Emory University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Prenatal DHA Supplements on Infant Development | ClinicalTrials.gov |
| NCT number | NCT00646360 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 1,094 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Emory University | ClinicalTrials.gov |
| Conditions | Pregnancy | ClinicalTrials.gov |
| Interventions | DHA, Placebo | ClinicalTrials.gov |
| First posted | 2008-03-28 | ClinicalTrials.gov |
| Last updated | 2022-06-07 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Birth size | 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. | ClinicalTrials.gov |
| Primary | Gestational age | Birth | Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the current date. | ClinicalTrials.gov |
| Primary | Changes in visual evoked potentials | 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. | ClinicalTrials.gov |
| Primary | Changes in infant weight | 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. | ClinicalTrials.gov |
| Primary | Changes in infant height | 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). | ClinicalTrials.gov |
| Primary | Changes In infant head circumference | 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). | ClinicalTrials.gov |
| Primary | Changes in auditory evoked potentials | 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. | ClinicalTrials.gov |
| Primary | Changes in child development score | 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. | ClinicalTrials.gov |
| Primary | Changes in Hearts and Flowers Stroop Test | 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. | ClinicalTrials.gov |
| Secondary | Changes Immune function | first 6 months of life | ClinicalTrials.gov | |
| Secondary | Changes in Morbidity | Birth, months 1, 3, 6, 9, 12, 18, 24, 36 and at 4 and 5 years of age | Changes in morbidity (health) factors will be assessed. | ClinicalTrials.gov |
| Secondary | Cognitive outcomes at age 7 years of age | At 7 year follow up | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 18
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 20715595 | DERIVED | PubMed |
| 21178076 | DERIVED | PubMed |
| 21178082 | DERIVED | PubMed |
| 21807696 | DERIVED | PubMed |
| 22739364 | DERIVED | PubMed |
| 23998234 | DERIVED | PubMed |
| 24626819 | DERIVED | PubMed |
| 25926416 | DERIVED | PubMed |
| 26262896 | DERIVED | PubMed |
| 26912491 | DERIVED | PubMed |
| 27604770 | DERIVED | PubMed |
| 28003539 | DERIVED | PubMed |
| 29617210 | DERIVED | PubMed |
| 29699913 | DERIVED | PubMed |
| 31334762 | DERIVED | PubMed |
| 34494106 | DERIVED | PubMed |
| 34543890 | DERIVED | PubMed |
| 37839707 | DERIVED | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Task Switching Test | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.