7. Change in nutritional status parameters: multiple micronutrients versus placebo.
| Trial ID | Nutritional parameter | Statistical measure | Intervention | Control | Timing of endpoint | Difference between groups at endpoint (as reported by trial authors) | ||||
| Baseline | Endpoint | N1 | Baseline | Endpoint | N1 | |||||
| Villamor 2008 TZA | BMI (kg/m2) | Mean (SD) | 19.3 (2.8) | Not reported | 233 | 19.6 (2.9) | 21.2 (3.3) |
238 | 2 years2 | MD ‐0.1 (−0.4 to 0.2); P = 0.37 |
| Guwatudde 2015 UG | Weight (kg) Haemoglobin (g/dL) |
Not reported Median (IQR) |
Not reported 12.2 (11.2 to 13.2) |
Not reported Not reported |
200 200 |
Not reported 12.3 (11.3 to 13.5) |
Not reported Not reported |
200 200 |
18 months 18 months |
MD 0.54 (−0.40 to 1.48); P = 0.691 MD 0.16 (−0.21 to 0.16); P = 0.977 |
| Jiamton 200312 | Blood vitamin E (µmol/L)3 | Mean (SD) | 22 (9) | Not reported | Not reported | 19 (7) | Not reported | Not reported | 48 weeks | MD 10.7 (7.0 to 14.3)4; P < 0.001 |
| Blood selenium (µmol/L)5 | Mean (SD) | 1.6 (0.2) | Not reported | Not reported | 1.6 (0.2) | Not reported | Not reported | 48 weeks | MD 0.16 (0.0 to 0.34)6; P = 0.04 | |
| Kelly 1999 ZMB12 | Blood vitamin A (µmol/L)7,8 | Mean | 0.63 | Not reported | 66 | 0.65 | Not reported | 69 | 4 weeks | P = 0.21 |
| Blood vitamin E (µmol/L)3,8 | Mean | 11.4 | Not reported | 66 | 11.7 | Not reported | 69 | 4 weeks | "No difference" | |
| Kelly 2008 ZMB | BMI (kg/m2) MUAC (cm) Fat mass (kg) Lean body mass (kg) Grip strength (kg) |
Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | Not reported | 1.9 years 9 | "No significant differences at any time point" |
| Semba 2007 MWI12 | Blood vitamin A (µmol/L)7,11 | Geometric mean | 0.59 | Reported in a graph | 383 | 0.59 | Reported in a graph | 397 | 8 months | "Significantly higher" |
| Blood selenium (µmol/L)10,11 | Geometric mean | 0.66 | Reported in a graph | 392 | 0.64 | Reported in graph | 405 | 8 months | ||
Abbreviations: BMI: Body Mass Index; IQR: Interquartile range; MUAC: Mid‐upper arm circumference; MD: Mean difference; SD: Standard deviation
1The number of participants stated is the number assessed for endpoint data. 2Villamor 2008 TZA also reported outcomes at 8 months, with no significant difference between groups (MD 0, 95% CI −0.2 to 0.3; P = 0.74). 3Reference value for vitamin E sufficiency ≥ 11.6 µmol/L. 4Jiamton 2003 THA: the trial authors reported endpoint data on a subset of 44 participants. The trial authors did not state the number of participants for each treatment group. Baseline vitamin E levels (µmol/L) reported for 112 participants. 5Reference value for selenium sufficiency: ≥ 0.95 µmol/L. 6Jiamton 2003 THA: the trial authors reported endpoint data on a subset of 54 participants. The number of participants for each treatment group is not stated. Baseline selenium levels (µmol/L) reported for 129 participants. 7Reference value for vitamin A deficiency: < 0.7 µmol/L. 8Kelly 1999 ZMB: the trial authors reported that 67% and 55% of participants were deficient in vitamins A and E, respectively, at baseline. 9Kelly 2008 ZMB was a cross‐over trial, with cross‐over at the end of 1.9 years. 10Reference value for selenium sufficiency: ≥ 0.75 µmol/L. 11Semba 2007 MWI: the trial authors reported that 60% and 75% of participants were deficient in vitamin A and selenium respectively, at baseline. 12Analysis of blood micronutrient concentrations did not include adjustment for biomarkers of inflammation.