Chen Ke1, Zhang Lan1, Li Hua2, Zhang Ying3, Xie Humina4, Shang Jia5, Tian Weizheng6, Yang Ping7, Chai Lingying8, Mao Meng9. 1. Department of Child Health Care, Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China. 2. Department of Preventive Health Care, Women and Children's Health Care Hospital of Qing Baijing, Qing Baijing District, Chengdu, Sichuan, China. 3. Department of Child Health Care, Women and Children's Health Care Hospital of Jinniu, Jinniu District, Chengdu, Sichuan, China. 4. Department of Child Health Care, Women and Children's Health Care Hospital of Dayi, Dayi County, Chengdu, Sichuan, China. 5. Department of Child Health Care, Women and Children's Health Care Hospital of Chenghua, Chenghua District, Chengdu, Sichuan, China. 6. Department of Pediatrics, Women and Children's Health Care Hospital of Dongpo, Dongpo District, Meishan, Sichuan, China. 7. Department of Child Health Care, Women and Children's Health Care Hospital of Xindu, Xindu District, Chengdu, Sichuan, China. 8. Beingmate Baby & Child Food Co., Ltd, Hangzhou, Zhejiang, China. 9. Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China. Electronic address: mmcdfy@163.com.
Abstract
OBJECTIVE: The aim of this study was to evaluate whether an iron-fortified formula with a concentration of lactoferrin would significantly improve the hematologic indexes and iron status in term infants compared with those same values in infants fed an iron-fortified formula without lactoferrin. METHOD: In this prospective, multicenter, controlled intervention study, 260 infants ages 4 to 6 mo were selected from six maternal and children's health care hospitals in the area. All infants were divided into two groups with the sequence of outpatient: lactoferrin-fortified formula milk group (fortified group, FG, containing lactoferrin 38 mg/100 g milk and iron element 4 mg/100 g milk) and no lactoferrin fortified milk (control group, CG, containing lactoferrin 0 mg/100 g milk and iron element 4 mg/100 g milk) for 3 mo. The levels of weight, height, and head circumference and the concentration of hemoglobin (Hb), serum ferritin (SF), andserum transferring receptor (sTfR) were measured and sTfR-SF index (TFR-F index), total body iron content (TBIC) and low height for age (HAZ), low weight for age (WAZ), and low weight for height (WHZ) were computed before and after the intervention, respectively. RESULTS: In all, 213 (115 in FG and 98 in CG) infants completed the intervention trial and all measurements of biochemical indicators. There were no significant differences in the average amount of daily intake of formula milk (94.3 ± 9.8 g versus 88.2 ± 8.7 g for FG and CG; P > 0.05) and iron element (3.8 ± 0.4 mg versus 3.7 ± 0.6 mg for FG and CG; P > 0.05). The average amount of daily intake of lactoferrin for infants in FG group was 35.8 ± 3.7 mg. The levels of weight, WAZ, WHZ, Hb, SF, TFR-F index, and TBIC after intervention of infants in FG were all significantly higher than those of infants in CG weight, 8723 ± 245 g versus 8558 ± 214g; WAZ, 1.02 ± 0.31 versus 0.44 ± 0.18; WHZ, 0.98 ± 0.31 versus 0.41 ± 0.12; Hb, 125.5 ± 15.4 g/L versus 116.9 ± 13.1 g/L; SF, 44.7 ± 17.2 μg/L versus 31.6 ± 18.4 μg/L; TFR-F index, 1.88 ± 0.41 versus 1.26 ± 0.39; TBIC, 6.12 ± 0.78 mg/kg versus 5.26 ± 0.55 mg/kg for FG and CG; P < 0.05), but significantly lower (P < 0.05) for the prevalence of anemia (4.1% versus 7.5%), iron deficiency (13.9% versus 24.4%), and iron-deficient anemia (1.7% versus 6.1%). CONCLUSION: When infants who were exclusively breastfed were supplemented with lactoferrin-fortified milk, significant increases in TBIC and iron absorption in the intestine were seen.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate whether an iron-fortified formula with a concentration of lactoferrin would significantly improve the hematologic indexes and iron status in term infants compared with those same values in infants fed an iron-fortified formula without lactoferrin. METHOD: In this prospective, multicenter, controlled intervention study, 260 infants ages 4 to 6 mo were selected from six maternal and children's health care hospitals in the area. All infants were divided into two groups with the sequence of outpatient: lactoferrin-fortified formula milk group (fortified group, FG, containing lactoferrin 38 mg/100 g milk and iron element 4 mg/100 g milk) and no lactoferrin fortified milk (control group, CG, containing lactoferrin 0 mg/100 g milk and iron element 4 mg/100 g milk) for 3 mo. The levels of weight, height, and head circumference and the concentration of hemoglobin (Hb), serum ferritin (SF), and serum transferring receptor (sTfR) were measured and sTfR-SF index (TFR-F index), total body iron content (TBIC) and low height for age (HAZ), low weight for age (WAZ), and low weight for height (WHZ) were computed before and after the intervention, respectively. RESULTS: In all, 213 (115 in FG and 98 in CG) infants completed the intervention trial and all measurements of biochemical indicators. There were no significant differences in the average amount of daily intake of formula milk (94.3 ± 9.8 g versus 88.2 ± 8.7 g for FG and CG; P > 0.05) and iron element (3.8 ± 0.4 mg versus 3.7 ± 0.6 mg for FG and CG; P > 0.05). The average amount of daily intake of lactoferrin for infants in FG group was 35.8 ± 3.7 mg. The levels of weight, WAZ, WHZ, Hb, SF, TFR-F index, and TBIC after intervention of infants in FG were all significantly higher than those of infants in CG weight, 8723 ± 245 g versus 8558 ± 214g; WAZ, 1.02 ± 0.31 versus 0.44 ± 0.18; WHZ, 0.98 ± 0.31 versus 0.41 ± 0.12; Hb, 125.5 ± 15.4 g/L versus 116.9 ± 13.1 g/L; SF, 44.7 ± 17.2 μg/L versus 31.6 ± 18.4 μg/L; TFR-F index, 1.88 ± 0.41 versus 1.26 ± 0.39; TBIC, 6.12 ± 0.78 mg/kg versus 5.26 ± 0.55 mg/kg for FG and CG; P < 0.05), but significantly lower (P < 0.05) for the prevalence of anemia (4.1% versus 7.5%), iron deficiency (13.9% versus 24.4%), and iron-deficient anemia (1.7% versus 6.1%). CONCLUSION: When infants who were exclusively breastfed were supplemented with lactoferrin-fortified milk, significant increases in TBIC and iron absorption in the intestine were seen.