Appendix 1 Table A1: Randomised Controlled Trials with DHA from various sources (and ARA) Reporting Growth Outcomes Study/Study Design ARA (%FA) DHA (%FA) Number of Subjects at longest duration (BF/C/DHA) DHA+ARA) Age at Start/Duration of Supplementation Outcome Summary Study Quality and Limitations Auestad et al. (1997) (2003) DB RCT 0.43 0.12 63/45/46 ~ 7 days/12 mo No difference in growth outcomes (weight, length, head circumference) between groups No difference in growth between groups 27 mo post- supplementation Quality - Groups comparable at baseline; selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured. Limitations – high drop-out rate (23%); limited follow-up (80%) at 27 mo post supplementation; sufficient statistical power not verified (i.e. no power calculation provided) Overall – moderate quality Auestad et al. (2001) DB RCT 0.45 0.14 82/77/162 ~9 days/12 mo No difference in growth (weight, length, head circumference) between groups Quality - Groups comparable at baseline; selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured; adequate statistical power, large study population. Limitations – high drop-out rate (27%) Overall – moderate-high quality
Clandinin et al. (2005)* DB RCT 0.64 0.32 76/62/117 14 days/~12 mo Feeding formulas with DHA and ARA from algal and fungal oils resulted in enhanced growth, i.e. weight and length significantly (P<.05) greater in response to DHA+ARA formula. Quality - selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured; adequate statistical power, large study population. Limitations – Groups differed somewhat at baseline; Drop-out rate 14% Overall – moderate quality Makrides et al. (1999) DB RCT 0.34 0.34 33/21/21 5-7 days/12 mo No difference in growth (weight, length, head circumference) between groups Quality - selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured. Limitations – Groups differed somewhat at baseline; Drop-out rate 18%; statistical power limited, i.e. n=25 per group required, n=21 completed. Overall – limited quality O’Connor et al. (2001)* DB RCT 0.41- 0.43 0.15- .0.27 43/91/180 ~3 days/12 mo No difference in growth (weight, length, head circumference) between groups Quality - Groups comparable at baseline; selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured; adequate statistical power, large study population. Limitations – drop-out rate (20%) Overall – moderate-high quality
Hoffman et al. (2000) DB RCT 0.72 0.36 20/20/18 4 ARA levels supported. DHA+ARA maintained ARA levels comparable to BF infants and significantly higher than C (P<.05). Quality – Appropriate outcomes, outcomes reliably measured. Limitations – Limited description of selection and allocation procedures described; disposition of subjects not provided; no power calculation provided. Overall – limited quality Makrides et al. (1999) DB RCT 0.34 0.34 33/21/21 12 ARA levels supported. At 34 and 52 wk DHA+ARA same as BF and significantly higher ARA than C or DHA-alone (P<.01). Quality - selection and allocation procedures described; disposition of subjects provided; appropriate outcomes, outcomes reliably measured. Limitations – Groups differed somewhat at baseline; Dropout rate 18%; statistical power limited, i.e. n=25 per group required, n=21 completed. Overall – limited quality