EAL

BF: Dietary Factors, Breast Milk and Infant Outcomes (2008)

Citation:

Jensen CJ, Voight RG, Prager TC, Zou YL, Fraley JK, Rozelle JC, Turich MR, Llorente AM, Anderson RE, Heird WC. Effects of maternal docosahexaunoic acid intake on visual function and neurodevelopment in breast-fed term infants. Am J Clin Nutr. 2005; 82: 125-132.

PubMed ID: 16002810

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To determine the effect of DHA supplementation of breastfeeding mothers on neurodevelopmental status and visual function in term infants.

Inclusion Criteria:

Pregnant women who planned to breastfeed exclusively for at least four months were recruited
Age 18 years to 40 years
Infant gestational age greater than 37 weeks
Infant birth weight 2,500g to 4,200g.

Exclusion Criteria:

Chronic maternal disorders
Major congenital anomalies
Obvious gastrointestinal or metabolic disorders of infants.

Description of Study Protocol:

Recruitment

Women recruited during pregnancy (those planning to breastfeed at least four months) via newspaper ads, flyers in doctors' offices and presentations at childbirth classes

Design

Randomized, double-blind controlled trial

Blinding used

Double-blind

Intervention

Moms received one of two identical capsules daily for four months, starting within five days after delivery

Capsule One: High- DHA algal triacylglycerol (DHASCO): 44% saturated FA, 13.6 MUFA, 0.8% linoleic acid, 41.7% DHA (approximately 200mg DHA per day)
Capsule Two: Control: 50:50 mixture of soy and corn oils: 15% saturated FA, 23.5% MUFA, 56.3% linoleic acid, 3.9 alpha-linolenic acid.

Statistical Analysis

ANCOVA, controlled for sex, ethnicity, maternal age, education, IQ, breastfeeding, birth weight, weight and body length at time of testing.

Data Collection Summary:

Timing of Measurements

21 days, two months, four months, eight months, 12 months, 18 months, 24 months and 30 months: Anthropometric measurements (length, weight and head circumference)
Four months postpartum: 24-hour milk collection; blood samples collected (Plasma and milk lipids)
Four and eight months postpartum: Binocular visual acuity assess (Teller Acuity Card procedure; sweep and transient visual evoked potentials)
12 months and 30 months of age:
- Gross motor development assessed (gross motor scale of Gesell Developmental Inventory)
- Language development (Clinical Linguistic and Auditory Milestone Scale)
- Visual-motor problem solving abilities (Clinical Adaptive Test)
30 months of age: Bayley Scales of Infant Development.

Dependent Variables

Performance at 30 months on Bayley Scales of Infant Development
FA pattern of milk lipids at four months postpartum
Infant plasma phospholipids at four and eight months postpartum
Infant visual function at four and eight months
Induces of neurodevelopmental status at 12 months and 30 months.

Independent Variables

Assignment to DHA or control capsule daily for four months.

Control Variables

Randomized, controlled treatment
Timing of measurements.

Description of Actual Data Sample:

Initial N

Moms

114 in DHA group (One group twins equals 115 infants)
113 in control group (Two groups of twins equals 115 infants).

Attrition (Final N)

12 months: 90 in DHA and 87 in control
30 months: 83 in DHA and 77 in control.

Age

Mom 31.5±5 years
Gestational age 39.4±1.4 years and 39.5±1.3 weeks (DHA and control, respectively).

Ethnicity

75% white, 19% black, 5% hispanic, 1% other (DHA)
79% white, 13% black, 6% hispanic, 2% other (Control).

Other relevant demographics

Mom's years of education:

15.9±2.2 years (DHA)
16.3±2.7 years (Control).

Anthropometrics

Infant (DHA and Control, respectively)

Birth weight 3.46±0.55kg, 3.48±0.51kg
Length not reported.

Location

Baylor College of Medicine and affiliated hospitals
University of Texas Health Sciences Center.

Summary of Results:

FA Composition of Breastmilk at Four Months Postpartum

Fatty Acid	DHA group (N=83)	Control Group (N=77)	Statistical Significance of Group Difference
18:3n-3	1.20±0.90	1.07±0.35	ns
20:5n-3	0.07±0.04	0.07±0.08	ns
22:5n-3	0.12±0.04	0.14±0.08	ns
22:6n-3	0.35±0.14	0.20±0.24	P<0.0001
18:2n-6	16.3±2.8	15.9±3.6	ns
20:4n-6	0.40±0.08	0.44±0.08	ns
22:4n-6	0.08±0.02	0.09±0.02	P<0.001
22:5n-6	0.04±0.01	0.05±0.02	P<0.004

NS effects of DHA were observed on visual acuity, gross motor, language and visual-motor problem solving development. It was observed, however, that infants of moms supplemented with DHA scored higher on the Psychomotor Development Index sub-score of the BSID at 30 months of age. NS correlations found between infant DHA status and any of functional outcomes.

Author Conclusion:

DHA supplementation of breastfeeding mothers results in higher (approximately 35%) infant plasma phospholipid DHA contents during supplementation and a higher Bayley Psychomotor Development Index at 30 months of age, but results in no other advantages (e.g., visual) either at or before 30 months of age.

Funding Source:

Government:

USDA, NRI

Industry:

Reviewer Comments:

Breast milk composition at four months was only analyzed for mothers who completed a 30-month follow-up. Drop-out rate at 30 months was 27% in DHA group; 32% in control group.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		No
	4.1.	Were follow-up methods described and the same for all groups?	No
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	No
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	Yes
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes