Sensitivity analyses and meta-regression for hemoglobin suggested a higher response with lower trial quality ( suboptimal allocation concealment and blinding ) , use of condiments , and sodium iron edetate and a lower response when adults were included .
Consumption of iron-fortified foods results in an improvement in hemoglobin , serum ferritin , and iron nutriture and a reduced risk of remaining anemic and iron deficient
BACKGROUND The utility of iron fortification of food to improve iron deficiency , anemia , and biological outcomes is not proven unequivocally .
Random serial sampling to evaluate efficacy of iron fortification: a randomized controlled trial of margarine fortification with ferric pyrophosphate or sodium iron edetate.
BACKGROUND R and om serial sampling is widely used in population pharmacokinetic studies and may have advantages compared with conventional fixed time-point evaluation of iron fortification . OBJECTIVE Our objective was to vali date r and om serial sampling to judge the efficacy of iron fortification of a low-fat margarine . DESIGN We conducted a 32-wk placebo-controlled , double-blind , iron-intervention trial in 18 - 40-y-old Swiss women ( n = 142 ) with serum ferritin ( SF ) concentrations < 25 μg/L. Women were r and omly assigned to 3 groups to receive 20 g margarine , with 14 mg added iron as either micronized ground ferric pyrophosphate ( MGFePP ) or sodium iron edetate ( NaFeEDTA ) , or placebo daily . We measured hemoglobin and iron status of subjects at 2 fixed time points ( at baseline and the endpoint ) plus 3 r and omly assigned time points between 4 and 28 wk . With the use of bootstrapping , the number of observations per individual was reduced to 3 and then compared with the 5-time-point data . Mixed-effects models were used to estimate iron repletion over time for r and om sampling , and analysis of covariance was used for fixed time-point sampling . RESULTS Body iron stores increased in women who received MGFePP or NaFeEDTA compared with women who received placebo ( P < 0.05 ) . The increase in body iron stores  with NaFeEDTA fortification was 2 - 3 times the increase with MGFePP fortification ( P < 0.05 ) ; the difference was more marked in women with baseline SF concentrations < 15 μg/L ( P < 0.05 ) . R and om serial sampling reduced the required sample size per group to one-tenth of that for 2 fixed time points . Compared with the 5-time-point analysis , the 3-time-point sparse sampling generated comparable estimates of efficacy . CONCLUSIONS When used to evaluate the efficacy of iron fortificants , r and om serial sampling can reduce the sample size , invasiveness , and costs while increasing sensitivity . R and om serial sampling more clearly describes the pattern of iron repletion and may prove useful in evaluating other micronutrient interventions
Sensitivity analyses and meta-regression for hemoglobin suggested a higher response with lower trial quality ( suboptimal allocation concealment and blinding ) , use of condiments , and sodium iron edetate and a lower response when adults were included .
Consumption of iron-fortified foods results in an improvement in hemoglobin , serum ferritin , and iron nutriture and a reduced risk of remaining anemic and iron deficient
BACKGROUND The utility of iron fortification of food to improve iron deficiency , anemia , and biological outcomes is not proven unequivocally .