Jaden Bendabenda1, Lotta Alho1, Ulla Ashorn1, Yin Bun Cheung2, Kathryn G Dewey3, Stephen A Vosti4, John Phuka5, Kenneth Maleta5, Per Ashorn1. 1. 1Department for International Health,University of Tampere School of Medicine,Tampere,Finland. 2. 3Centre for Quantitative Medicine,Duke-National University of Singapore Graduate Medical School,Singapore,Singapore. 3. 4Department of Nutrition,University of California,Davis,Davis,CA,USA. 4. 5Department of Agricultural and Resource Economics,University of California,Davis,Davis,CA,USA. 5. 2School of Public Health and Family Medicine,University of Malawi College of Medicine,Postgraduate Building,Mahatma Gandhi Road,Private Bag 360,Blantyre 3,Malawi.
Abstract
OBJECTIVE: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children. DESIGN: Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %. SETTING:Namwera and Mangochi catchment areas in rural Malawi. SUBJECTS:Infants aged 6 months (n 1932). RESULTS:The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups. CONCLUSIONS: Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.
RCT Entities:
OBJECTIVE: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children. DESIGN: Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %. SETTING: Namwera and Mangochi catchment areas in rural Malawi. SUBJECTS:Infants aged 6 months (n 1932). RESULTS: The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups. CONCLUSIONS: Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.
Authors: Jai K Das; Rehana A Salam; Yousaf Bashir Hadi; Sana Sadiq Sheikh; Afsah Z Bhutta; Zita Weise Prinzo; Zulfiqar A Bhutta Journal: Cochrane Database Syst Rev Date: 2019-05-02
Authors: Sania Ashraf; Mahfuza Islam; Leanne Unicomb; Mahbubur Rahman; Peter J Winch; Benjamin F Arnold; Jade Benjamin-Chung; Pavani K Ram; John M Colford; Stephen P Luby Journal: Am J Trop Med Hyg Date: 2020-05 Impact factor: 2.345
Authors: Cornelius M Smuts; Tonderayi M Matsungo; Linda Malan; Herculina S Kruger; Marinel Rothman; Jane D Kvalsvig; Namukolo Covic; Karen Joosten; Saskia J M Osendarp; Maaike J Bruins; Leon G J Frenken; Carl J Lombard; Mieke Faber Journal: Am J Clin Nutr Date: 2019-01-01 Impact factor: 7.045