#194 Needed for Eye and Brain Development? Omega-3s in infant formula

CLINICAL QUESTION

QUESTION CLINIQUE

Does adding omega-3 long-chain polyunsaturated fatty acids to infant formula improve brain and eye development in healthy, full-term infants?

BOTTOM LINE

RÉSULTAT FINAL

Adding omega-3 to infant formula has no consistently meaningful effects on neurocognitive development. One group using one measure of visual acuity consistently found benefits (about 1-line difference on Snellen chart) at 12 months that others do not and long-term data is lacking.

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EVIDENCE

DONNÉES PROBANTES

Neuro-cognition:
- Five of seven highest quality Systematic Reviews (SR) found no consistent benefit.^1-5
- Remaining two SR that found benefit: ^6,⁷
  - SR of four Randomized Controlled Trials [RCTs (376 patients)].⁶ Compared to no omega-3, omega-3 statistically improved:
    - Mental and Psychomotor Development Indices, by standard mean differences of 0.27-0.33, which is difficult to interpret clinically (but suggest small).
    - Limitations: Inconsistent data reporting, results mainly driven by one industry-funded trial.⁸
  - SR of studies between 2008-2013.⁷
    - Two meta-analyses found no effect on cognition.
    - Seven RCTs not included in the meta-analyses provide inconsistent results.
    - Limitations: Conclusions not based on the totality of the evidence.
Vision:
- Within omega-3 Cochrane SR, eight RCTs examined visual acuity.²
  - Four RCTs (495 participants) found no effect.
  - Three RCTs (244 participants) pooled found omega-3 better on sweep visual evoked potentials (VEP), equivalent to approximately 1-line on Snellen chart.
  - Another RCT (32 participants) found benefit at different time-points with different tests.
  - Limitations: High drop-outs (follow-up 70-86% complete), most benefit seen by one research group.
- SR of nine RCTs (1,131 participants):⁹
  - Omega-3 improved acuity using VEP at 2, 4, and 12 months (approximately 1-line better on Snellen chart, inconsistent results), but no difference using other methods.
- Other reviews found similar, inconsistent effects.^1,10
Limitations:
- Clinical relevance unknown.
- Multiple outcomes reported likely leading to ‘chance findings’.
  - Example: One study found better vision in right eye with omega-3 at four years, but not left eye.^10,11

Context:

There is no optimal neurocognitive assessment measure for infants.
The minimum clinically important differences in the most commonly used neurocognitive scales are unknown.^4,8,12
Formula containing omega-3 costs more than formula without omega-3.