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Public Health Nutr. 2016 Jul;19(10):1893-903. doi: 10.1017/S1368980016000331. Epub 2016 Mar 9.

The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial.

Author information

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00945698.

KEYWORDS:

Children; Infectious disease morbidity; Iron; Lipid-based nutrient supplements; Low-income countries

PMID:
26956611
DOI:
10.1017/S1368980016000331
[Indexed for MEDLINE]

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