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Predicting potential to benefit from an iron intervention: a randomized controlled trial of double-fortified salt in female Indian tea pluckers.

ABSTRACT: OBJECTIVE:The present study examines characteristics of those who benefited from a dietary Fe intervention comprised of salt double-fortified with iodine and Fe (DFS). DESIGN:Data from a randomized controlled trial were analysed to identify predictors of improved Fe status and resolution of Fe deficiency (serum ferritin (sFt) < 12 ?g/l) and low body Fe (body Fe (BI) < 0·0 mg/kg) using non-parametric estimations and binomial regression models. SETTING:A tea estate in West Bengal, India. PARTICIPANTS:Female tea pluckers, aged 18-55 years. RESULTS:Consuming DFS significantly (P = 0·01) predicted resolution of Fe deficiency (relative risk (RR) = 2·31) and of low BI (RR = 2·78) compared with consuming iodized salt. Baseline sFt (? = -0·32 (se 0·03), P < 0·001) and treatment group (? = 0·13 (se 0·03), P < 0·001) significantly predicted change in sFt. The interaction of baseline BI with treatment group (? = -0·11 (se 0·06), P = 0·08) predicted the change in BI. DFS did not significantly predict change in Hb and marginally predicted resolution of anaemia (Hb < 120 g/l). CONCLUSIONS:Baseline Fe status, as assessed by sFt and BI, and consumption of DFS predict change in Fe status and resolution of Fe deficiency and low BI. Anaemia prevalence and Hb level, although simple and inexpensive to measure, may not be adequate to predict resolution of Fe deficiency in response to an intervention of DFS in similar populations with high prevalence of Fe deficiency and multiple nutritional causes of anaemia. These findings will guide appropriate targeting of future interventions.

SUBMITTER: Nevins JE

PROVIDER: S-EPMC6891141 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Predicting potential to benefit from an iron intervention: a randomized controlled trial of double-fortified salt in female Indian tea pluckers.

Nevins Julie Eh JE Venkatramanan Sudha S Mehta Saurabh S Haas Jere D JD

Public health nutrition 20190725 18

<h4>Objective</h4>The present study examines characteristics of those who benefited from a dietary Fe intervention comprised of salt double-fortified with iodine and Fe (DFS).<h4>Design</h4>Data from a randomized controlled trial were analysed to identify predictors of improved Fe status and resolution of Fe deficiency (serum ferritin (sFt) < 12 μg/l) and low body Fe (body Fe (BI) < 0·0 mg/kg) using non-parametric estimations and binomial regression models.<h4>Setting</h4>A tea estate in West Be ...[more]

PMID: 31342886

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Project description:Double-fortified salt (DFS) containing iron and iodine has been proposed as a feasible and cost-effective alternative for iron fortification in low- and middle-income countries (LMICs). We conducted a systematic review and meta-analysis from randomized and quasi-randomized controlled trials to 1) assess the effect of DFS on biomarkers of iron status and the risk of anemia and iron deficiency anemia (IDA) and 2) evaluate differential effects of DFS by study type (efficacy or effectiveness), population subgroups, iron formulation (ferrous sulfate, ferrous fumarate, and ferric pyrophosphate), iron concentration, duration of intervention, and study quality. A systematic search with the use of MEDLINE, EMBASE, Cochrane, Web of Science, and other sources identified 221 articles. Twelve efficacy and 2 effectiveness studies met prespecified inclusion criteria. All studies were conducted in LMICs: 10 in India, 2 in Morocco, and 1 each in Côte d'Ivoire and Ghana. In efficacy studies, DFS increased hemoglobin concentrations [standardized mean difference (SMD): 0.28; 95% CI: 0.11, 0.44; P < 0.001] and reduced the risk of anemia (RR: 0.59; 95% CI: 0.46, 0.77; P < 0.001) and IDA (RR 0.37; 95% CI: 0.25, 0.54; P < 0.001). In effectiveness studies, the effect size for hemoglobin was smaller but significant (SMD: 0.03; 95% CI: 0.01, 0.05; P < 0.01). Stratified analyses of efficacy studies by population subgroups indicated positive effects of DFS among women and school-age children. For the latter, DFS increased hemoglobin concentrations (SMD: 0.32; 95% CI: 0.03, 0.60; P < 0.05) and reduced the risk of anemia (SMD: 0.48; 95% CI: 0.34, 0.67; P < 0.001) and IDA (SMD: 0.37; 95% CI: 0.25, 0.54; P < 0.001). Hemoglobin concentrations, anemia prevalence and deworming at baseline, sample size, and study duration were not associated with effect sizes. The results indicate that DFS is efficacious in increasing hemoglobin concentrations and reducing the risk of anemia and IDA in LMIC populations. More effectiveness studies are needed.

Project description:BackgroundDouble-fortified salt (DFS) is a vehicle for dual fortification with iron and iodine, to reduce their respective deficiencies. This background article is the third in a series reviewing available research, analyses, and experiences on DFS as an effective delivery vehicle for iron and iodine.ObjectivesThe objective of this article is to systematically evaluate current programs distributing DFS around the world and catalogue opportunities, risks, and challenges related to programs that incorporate DFS. We carried out a narrative review of DFS programs from around the world with our data sources deriving from a mix of a nonsystematic literature search and interviews with key informants.MethodsWe assessed programmatic experience with DFS from social safety net programs in India (from the states of Bihar, Madhya Pradesh, and Uttar Pradesh) and from non-social safety net country programs or projects in Argentina, Cote d'Ivoire, Kenya, Morocco, Nigeria, Philippines, and Sri Lanka.ResultsFindings revealed color change of the final DFS product was an issue in 9 of the 14 programs or studies reviewed and was the most significant challenge that had a direct impact on consumer acceptance and uptake regardless of type of program (open market or social safety net). Other challenges identified were related to the quality of the salt and lack of DFS formulation standards and regulatory monitoring protocols.ConclusionsDFS programs need to focus on 1) improved technology with better consumer acceptance and better performance when used with lower-quality salt; 2) elucidation and enforcement of DFS formulation quality standards, along with producer incentives; and 3) strong government backing at the policy level. DFS offers a unique opportunity to leverage an almost universally consumed product with the addition of 2 important nutrients missing in many populations. However, program "maturity" will take time with urgent attention needed for quality production.

Project description:BACKGROUND:Bouillon cubes are a potential vehicle for iron fortification. They are currently fortified with ferric pyrophosphate (FePP), which is known to be poorly absorbed. The objective of this study was to assess the iron absorption of Aspergillus oryzae grown in FePP (ASP-p) and compare it with FePP and ferrous sulfate (FeSO4)-fortified bouillon cubes. METHODS:In 2 single-blinded, crossover studies, healthy women with serum ferritin concentrations <40 μg/L were randomly assigned to consume a rice-vegetable meal with iron-fortified chicken bouillon. Subjects in study I (n = 17, 18-26 y) consumed iron from both iron sources as 57FePP and 58ASP-p (intrinsically labeled with 58FePP) with a meal containing 4.2 mg of total iron provided for 3 d. Study II (n = 18, 18-29 y) was similar except that subjects consumed 57FeSO4 and 58ASP-p. Whole-blood stable isotope enrichment after 14 d was used to measure fractional iron absorption. Hemoglobin, hematocrit, serum ferritin, hepcidin, and serum C-reactive protein were analyzed at baseline and at 14 d. A t test was used to compare the mean differences in fractional absorptions within each study and baseline characteristics between studies. RESULTS:Geometric mean (95% CI) fractional iron absorption of FePP [0.94% (0.63%, 1.40%)] was lower than ASP-p [2.20% (1.47%, 3.30%)] (P < 0.0001) in study I. In study II, ASP-p fractional absorption [2.98% (2.03%, 4.38%)] was lower than that of FeSO4 [9.88% (6.70%, 14.59%)] (P < 0.0001). Both ferritin (r = -0.41, P = 0.014) and hepcidin (r = -0.42, P = 0.01) concentrations were inversely correlated with ASP-p iron absorption. Fractional absorption of ASP-p was also positively correlated with FePP (r = 0.92, P < 0.0001) and FeSO4 (r = 0.52, P < 0.02) absorption. CONCLUSIONS:ASP-p-fortified bouillon provided 2.3-fold higher absorbable iron than the currently used FePP. Bouillon fortified with ASP-p may contribute sufficient bioavailable iron to meet the daily iron requirements in young women only if consumed with other iron-fortified staple foods. This trial was registered at clinicaltrials.gov as NCT03586245.

Project description:BACKGROUND:Lentils are generally considered to be a nutrient-dense food, and a good source of iron (Fe). This study aims to establish novel evidence of the effectiveness of the consumption of Fe-fortified lentils in improving the body Fe status and thus cognitive performance in non-pregnant adolescent girls in rural Bangladesh, compared to consumption of ordinary lentils. METHODS:We have designed a double-blind (both trial participants and outcome assessors), community-based, cluster-randomized controlled trial among 1260 Bangladeshi adolescent girls between the ages of 10-17?years who are non-smoking, not married, not pregnant, not breastfeeding, and generally healthy at the time of enrollment. The intervention will include three arms who will receive: (1) Fe-fortified lentils; (2) unfortified lentils; or (3) usual intake. Participants will be served a thick preparation of cooked Fe-fortified lentils (37.5?g raw lentils, approximately 200?g cooked lentils) 5?days per week for 85 feeding days (around 4?months) using a locally acceptable recipe. Lentils were fortified with Fe in the laboratory at the Department of Plant Sciences at the University of Saskatchewan in Canada. A subsample of participants (n?=?360) will be randomly invited to be included in cognitive testing. DISCUSSION:Data on socio-demographic characteristics, household food security status, adolescent food habits and cognitive testing will be collected at baseline and endline (4?months). Venous blood samples will be collected at baseline, midline (2?months) and endline to measure adolescents' Fe status. Computerized cognitive testing will include five common measures of attentional (three of attention) and mnemonic functioning (two of memory) carried out using DMDX software. The results of this study will be used to garner support for and to substantiate large-scale production and market expansion of Fe-fortified lentils, and will contribute to knowledge about how to enhance Fe status in adolescents worldwide in resource-poor settings, using staple food crops. TRIAL REGISTRATION:ClinicalTrials.gov NCT03516734 . Registered on 24 May 2018.

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Predicting potential to benefit from an iron intervention: a randomized controlled trial of double-fortified salt in female Indian tea pluckers.

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Predicting potential to benefit from an iron intervention: a randomized controlled trial of double-fortified salt in female Indian tea pluckers.

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