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A macro- and micronutrient-fortified complementary food supplement reduced acute infection, improved haemoglobin and showed a dose-response effect in improving linear growth: a 12-month cluster randomised trial.

ABSTRACT: Inadequate protein quality may be a risk factor for poor growth. To examine the effect of a macronutrient-micronutrient supplement KOKO Plus (KP), provided to infants from 6 to 18 months of age, on linear growth, a single-blind cluster-randomised study was implemented in Ghana. A total of thirty-eight communities were randomly allocated to receive KP (fourteen communities, n 322), a micronutrient powder (MN, thirteen communities, n 329) and nutrition education (NE, eleven communities, n 319). A comparison group was followed cross-sectionally (n 303). Supplement delivery and morbidity were measured weekly and anthropometry monthly. NE education was provided monthly. Baseline, midline and endline measurements at 6, 12 and 18 months included venous blood draws, diet, anthropometry, morbidity, food security and socio-economics. Length-for-age Z-score (LAZ) was the primary outcome. Analyses were intent-to-treat using mixed-effects regressions adjusted for clustering, sex, age and baseline. No differences existed in mean LAZ scores at endline (-1·219 (sd 0·06) KP, -1·211 (sd 0·03) MN, -1·266 (sd 0·03) NE). Acute infection prevalence was lower in the KP than NE group (P = 0·043). Mean serum Hb was higher in KP infants free from acute infection (114·02 (sd 1·87) g/l) than MN (107·8 (sd 2·5) g/l; P = 0·047) and NE (108·8 (sd 0·99) g/l; P = 0·051). Compliance was 84·9 % (KP) and 87·2 % (MN) but delivery 60 %. Adjusting for delivery and compliance, LAZ score at endline was significantly higher in the KP v. MN group (+0·2 LAZ; P = 0·026). A macro- and micronutrient-fortified supplement KP reduced acute infection, improved Hb and demonstrated a dose-response effect on LAZ adjusting consumption for delivery.

SUBMITTER: Ghosh SA

PROVIDER: S-EPMC6598226 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A macro- and micronutrient-fortified complementary food supplement reduced acute infection, improved haemoglobin and showed a dose-response effect in improving linear growth: a 12-month cluster randomised trial.

Ghosh Shibani A SA Strutt Nicholas R NR Otoo Gloria E GE Suri Devika J DJ Ankrah Judith J Johnson Thomas T Nsiah Paul P Furuta Chie C Murakami Hitoshi H Perera Gillian G Chui Kenneth K Bomfeh Kennedy K Amonoo-Kuofi Harold H Tano-Debrah Kwaku K Uauy Ricardo R

Journal of nutritional science 20190627

Inadequate protein quality may be a risk factor for poor growth. To examine the effect of a macronutrient-micronutrient supplement KOKO Plus (KP), provided to infants from 6 to 18 months of age, on linear growth, a single-blind cluster-randomised study was implemented in Ghana. A total of thirty-eight communities were randomly allocated to receive KP (fourteen communities, <i>n</i> 322), a micronutrient powder (MN, thirteen communities, <i>n</i> 329) and nutrition education (NE, eleven communiti ...[more]

PMID: 31275576

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Project description:Iron deficiency (ID) and malaria co-exist in tropical regions and both contribute to high rates of anaemia in young children. It is unclear whether iron fortification combined with intermittent preventive treatment (IPT) of malaria would be an efficacious strategy for reducing anaemia in young children.A 9-month cluster-randomised, single-blinded, placebo-controlled intervention trial was carried out in children aged 12-36 months in south-central Côte d'Ivoire, an area of intense and perennial malaria transmission. The study groups were: group 1: normal diet and IPT-placebo (n = 125); group 2: consumption of porridge, an iron-fortified complementary food (CF) with optimised composition providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferrous fumarate 6 days per week (CF-FeFum) and IPT-placebo (n = 126); group 3: IPT of malaria at 3-month intervals, using sulfadoxine-pyrimethamine and amodiaquine and no dietary intervention (n = 127); group 4: both CF-FeFum and IPT (n = 124); and group 5: consumption of porridge, an iron-fortified CF with the composition currently on the Ivorian market providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferric pyrophosphate 6 days per week (CF-FePP) and IPT-placebo (n = 127). The primary outcome was haemoglobin (Hb) concentration. Linear and logistic regression mixed-effect models were used for the comparison of the five study groups, and a 2 × 2 factorial analysis was used to assess treatment interactions of CF-FeFum and IPT (study groups 1-4).After 9 months, the Hb concentration increased in all groups to a similar extent with no statistically significant difference between groups. In the 2 × 2 factorial analysis after 9 months, no treatment interaction was found on Hb (P = 0.89). The adjusted differences in Hb were 0.24 g/dl (95 % CI -0.10 to 0.59; P = 0.16) in children receiving IPT and -0.08 g/dl (95 % CI -0.42 to 0.26; P = 0.65) in children receiving CF-FeFum. At baseline, anaemia (Hb <11.0 g/dl) was 82.1 %. After 9 months, IPT decreased the odds of anaemia (odds ratio [OR], 0.46 [95 % CI 0.23-0.91]; P = 0.023), whereas iron-fortified CF did not (OR, 0.85 [95 % CI 0.43-1.68]; P = 0.68), although ID (plasma ferritin <30 ?g/l) was decreased markedly in children receiving iron fortified CF (OR, 0.19 [95 % CI 0.09-0.40]; P < 0.001).IPT alone only modestly decreased anaemia, but neither IPT nor iron fortified CF significantly improved Hb concentration after 9 months. Additionally, IPT did not augment the effect of the iron fortified CF. CF fortified with highly bioavailable iron improved iron status but not Hb concentration, despite three-monthly IPT of malaria. Thus, further research is necessary to develop effective combination strategies to prevent and treat anaemia in malaria endemic regions.http://www.clinicaltrials.gov ; identifier NCT01634945; registered on July 3, 2012.

Project description:Poor micronutrient status is reported among adolescents across Europe and USA. This may be related to the well-documented decline in the regular consumption of breakfast by this group. The regular consumption of a breakfast cereal offers a possible means to improve micronutrient status; fortified cereal is likely to have enhanced benefit. A study was conducted to determine the efficacy of the regular consumption of a fortified cereal with milk, compared with unfortified cereal, consumed either as a breakfast or a supper, in improving micronutrient intake and micronutrient status of adolescent girls.A randomised, double-blind, placebo-controlled intervention trial was conducted in girls recruited at ages 16-19 years, from schools and colleges in Sheffield, UK. Girls were randomised to receive 50 g fortified or unfortified cereal, with 150 ml semi-skimmed milk, daily, for 12 weeks, as a breakfast or as a supper. Dietary intake was estimated using a 4-d food diary and blood collected for the assessment of nutritional status. Within-group changes were tested using a paired sample t test; two-way ANOVA was used to analyse effects of the intervention, with cereal type and time of consumption as factors, correcting for baseline values. The analysis was conducted on 71 girls who completed the study.Consumption of unfortified cereal elicited an increase in the intake of vitamins B1, B2 and B6; consumption of fortified cereal elicited increases in vitamins B1, B2, B6, B12, folate and iron (P < 0.001) and of vitamin D (P = 0.007), all increases were significantly greater than for unfortified cereal. Consumption of the fortified cereal also led to a significant improvement in biomarkers of status for vitamins B2, B12, folate and of iron, compared with girls receiving the unfortified cereal, and maintained vitamin D status, in contrast with the girls receiving the unfortified cereal (P < 0.001).The daily consumption of cereal with milk for 12 weeks by adolescent girls, increased intakes of micronutrients. The consumption of fortified cereal elicited greater increases than for unfortified cereal and improved biomarkers of micronutrient status. The findings justify strategies to encourage the consumption of fortified cereal with milk by adolescents, either as a breakfast or a supper.Registered with Current Controlled Trials (Registration: ISRCTN55141306 ).

Project description:BackgroundAppropriate feeding of infants and young children is essential for healthy growth and the prevention of stunting, wasting, and overweight. We aimed to assess the beneficial versus harmful effects of providing fortified complementary foods to children in the complementary feeding period.MethodsIn this systematic review and meta-analysis, we searched the databases Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature, Global Index Medicus, Web of Science, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform from inception to March 9, 2021. We included randomised controlled trials and controlled clinical trials done in infants and children aged 6-23 months with no identified health problems. Consumption of foods fortified centrally (ie, during industrial processing) with one micronutrient or a combination of vitamins, minerals, or both was compared with the same complementary foods, but without micronutrient fortification. Two review authors independently screened studies for eligibility, extracted data, assessed risk of bias, and rated the certainty of the evidence. The main outcomes were growth (measured by Z scores for weight for age, weight for height or length, and height or length for age, or other growth measures), stunting, wasting, nutrient adequacy or excess, anaemia, haemoglobin concentration, iron status, serum zinc concentration, and serum retinol concentration. We used a random-effects meta-analysis for combining data. This study is registered with PROSPERO, CRD42021245876.FindingsWe included 16 studies with 6423 participants, 13 of which were done in malaria-endemic areas. Overall, 12 studies were included in the quantitative syntheses. We identified five further ongoing studies. There was no difference between participants who received fortified complementary foods and those who received non-fortified complementary foods in weight-for-age Z scores (mean difference -0·01, 95% CI -0·07 to 0·06; five trials; 1206 participants; moderate-certainty evidence), weight-for-height or length Z scores (-0·05, -0·19 to 0·10; four trials; 1109 participants; moderate-certainty evidence), and height or length-for-age Z scores (-0·01, -0·21 to 0·20; four trials; 811 participants; low-certainty evidence); stunting and wasting were not assessed in any study as outcomes. Moderate-certainty evidence from six trials with 1209 patients showed that providing fortified complementary foods to children aged 6-23 months reduced the risk of anaemia (risk ratio 0·57, 95% CI 0·39 to 0·82). Those who received fortified complementary foods compared with those who did not had higher haemoglobin concentrations (mean difference 3·44 g/L, 95% CI 1·33 to 5·55; 11 trials; 2175 participants; moderate-certainty evidence) and ferritin concentration (0·43 μg/L on log scale, 0·14 to 0·72; six trials; 903 participants; low-certainty evidence). The intervention led to no effects on serum zinc concentration (-0·13 g/dL, -0·82 to 0·56; two trials; 333 participants; low-certainty evidence) and serum retinol concentration (0·03 μmol/L, -0·02 to 0·08; five trials; 475 participants; moderate-certainty evidence).InterpretationFortified complementary foods are effective strategies to prevent anaemia in infants and young children aged 6-23 months in malaria-endemic regions. Effects of complementary food fortification should be further investigated in low-income and middle-income countries, but should also be assessed in high-income countries, and in regions where malaria is not endemic.FundingWHO.

Project description:Fortification of staple foods is considered an effective and safe strategy to combat micronutrient deficiencies, thereby improving health. While improving micronutrient status might be expected to have positive effects on immunity, some studies have reported increases in infections or inflammation after iron supplementation.To study effects of micronutrient-fortified rice on hookworm infection in Cambodian schoolchildren.A double-blinded, cluster-randomized trial was conducted in 16 Cambodian primary schools partaking in the World Food Program school meal program. Three types of multi-micronutrient fortified rice were tested against placebo rice within the school meal program: UltraRice_original, UltraRice_improved and NutriRice. Four schools were randomly assigned to each study group (placebo n = 492, UltraRice_original n = 479, UltraRice_improved n = 500, NutriRice n = 506). Intestinal parasite infection was measured in fecal samples by Kato-Katz method at baseline and after three and seven months. In a subgroup (N = 330), fecal calprotectin was measured by ELISA as a marker for intestinal inflammation.Baseline prevalence of hookworm infection was 18.6%, but differed considerably among schools (range 0%- 48.1%).Micronutrient-fortified rice significantly increased risk of new hookworm infection. This effect was modified by baseline hookworm prevalence at the school; hookworm infection risk was increased by all three types of fortified rice in schools where baseline prevalence was high (>15%), and only by UltraRice_original in schools with low baseline prevalence. Neither hookworm infection nor fortified rice was related to fecal calprotectin.Consumption of rice fortified with micronutrients can increase hookworm prevalence, especially in environments with high infection pressure. When considering fortification of staple foods, a careful risk-benefit analysis is warranted, taking into account severity of micronutrient deficiencies and local prevalence of parasitic infections.ClinicalTrials.gov NCT01706419.

Dataset Information

A macro- and micronutrient-fortified complementary food supplement reduced acute infection, improved haemoglobin and showed a dose-response effect in improving linear growth: a 12-month cluster randomised trial.

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A macro- and micronutrient-fortified complementary food supplement reduced acute infection, improved haemoglobin and showed a dose-response effect in improving linear growth: a 12-month cluster randomised trial.

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