Iron supplementation of breastfed Gambian infants from 6 weeks to 6 months of age: protocol for a randomised controlled trial

Wellcome Open Research

article

Isabella Stelle¹  Mamadou Bah²  Sergio A. Silverio¹  Hans Verhoef³  Ebrima Comma²  Andrew M. Prentice²  Sophie E. Moore¹  Carla Cerami² 

[1] Department of Women and Children's Health, King's College London, 10th Floor North Wing, St. Thomas' Hospital;Nutrition and Planetary Health Theme, MRC Unit The Gambia @ the London School of Hygiene and Tropical Medicine;Division of Human Nutrition and Health, Wageningen University

关键词: iron deficiency;    anaemia;    supplements;    iron;    infants;    global health;    nutrition intervention;    breastfeeding;   

DOI  :  10.12688/wellcomeopenres.17507.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background:10 μmol/L). The development and function of neural and immune cells may thus be compromised before the minimum age at which children should receive iron supplementation as per World Health Organisation recommendations.Methods: This study is a two-arm, double-blind, placebo-controlled, randomised superiority trial. Infants will be randomised to receive iron drops (7.5mg/day of iron as ferrous sulphate) or placebo daily for 98 days, to test the impact on serum iron concentrations in healthy, breastfed infants (n = 100) aged 6-10 weeks at enrolment. Participants will be visited daily and supplemented by the field team. Daily health and weekly breastfeeding questionnaires will be administered. Anthropometry, and venous blood and faecal samples will be collected at enrolment and after 98 days of supplementation with serum iron as the primary endpoint. Low birthweight (less than 2.5kg at birth) and infants born prematurely (< 37 weeks) will not be excluded. Formula-fed and infants with any illness will be excluded. An additional study exploring maternal stakeholder perspectives of the intervention will be conducted by means of maternal interviews and four focus group discussions with local stakeholders.Discussion: Most breast-fed Gambian infants have very low circulating iron levels by five months of age. This study will introduce iron supplements much earlier in infancy than has previously been attempted in a low-income setting with the primary aim of increasing serum iron concentration.

【 授权许可】

CC BY