Dataset Information

Efficacy of high zinc biofortified wheat in improvement of micronutrient status, and prevention of morbidity among preschool children and women - a double masked, randomized, controlled trial.

ABSTRACT:

Background

Biofortification of staple food crops with zinc (Zn) can be one of the cost-effective and sustainable strategies to combat zinc deficiency and prevent morbidity among the target population. Agronomic approaches such as application of Zn fertilizers to soil and/or foliar spray seem to be a practical tool for Zn biofortification of wheat. However, there is a need to evaluate its efficacy from randomized controlled trials. This study aimed to evaluate the efficacy of zinc biofortified wheat flour on zinc status and its impact on morbidity among children aged 4-6 years and non-pregnant non lactating woman of child bearing age (WCBA) in Delhi, India.

Methods

In a community based, double-masked randomized controlled trial, 6005 participants (WCBA and child pairs) were enrolled and randomly allocated to receive either high zinc biofortified wheat flour (HZn, 30 ppm zinc daily) or low zinc biofortified wheat flour (LZn, 20 ppm zinc daily) for 6 months (WCBA @ 360 g/day and children @ 120 g/day). Baseline and endline blood samples were obtained for assessing hematological markers; zinc status and data on compliance and morbidity were collected.

Results

Compliance rates were high; ~?88% of the WCBAs in both the groups consumed 50% or more of recommended amount of biofortfied wheat flour during the follow up. Similarly 86.9% children in HZn and 87.5% in LZn consumed 50% or more of recommended wheat flour intake. There was no significant difference in mean zinc levels between the groups at end study. This observation might be due to a marginal difference in zinc content (10 ppm) between the HZn and LZn wheat flour, and a short intervention period. However a positive impact of bio-fortification on self-reported morbidity was observed. Compared to children in LZn group, children in HZn group had 17% (95% CI: 6 to 31%, p?=?0.05) and 40% (95% CI: 16 to 57%; p?=?0.0019) reduction in days with pneumonia and vomiting respectively. WCBA in the HZn group also showed a statistically significant 9% fewer days with fever compared to LZn group.

Conclusions

Biofortified wheat flour had a good compliance among children and WCBAs. Significant improvement on some of the self-reported morbidity indicators suggests that evaluating longer-term effects of biofortification with higher grain zinc content would be more appropriate.

Trial registration

http://ctri.nic.in/Clinicaltrials/ , CTRI/2014/04/004527, Registered April 7, 2014.

SUBMITTER: Sazawal S

PROVIDER: S-EPMC6139156 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

Efficacy of high zinc biofortified wheat in improvement of micronutrient status, and prevention of morbidity among preschool children and women - a double masked, randomized, controlled trial.

Sazawal Sunil S Dhingra Usha U Dhingra Pratibha P Dutta Arup A Deb Saikat S Kumar Jitendra J Devi Prabhabati P Prakash Ashish A

Nutrition journal 20180915 1

<h4>Background</h4>Biofortification of staple food crops with zinc (Zn) can be one of the cost-effective and sustainable strategies to combat zinc deficiency and prevent morbidity among the target population. Agronomic approaches such as application of Zn fertilizers to soil and/or foliar spray seem to be a practical tool for Zn biofortification of wheat. However, there is a need to evaluate its efficacy from randomized controlled trials. This study aimed to evaluate the efficacy of zinc biofort ...[more]

PMID: 30219062

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Project description:BackgroundZinc biofortification of rice could sustainably improve zinc status in countries where zinc deficiency is common and rice is a staple, but its efficacy has not been tested. Fatty acid desaturases (FADS) are putative new zinc status biomarkers.ObjectivesOur objective was to test the efficacy of zinc-biofortified rice (BFR) in preschool-aged children with zinc deficiency. Our hypothesis was that consumption of BFR would increase plasma zinc concentration (PZC).MethodsWe conducted a 9-mo, double-masked intervention trial in 12-36-mo-old rural Bangladeshi children, most of whom were zinc-deficient (PZC <70 µg/dL) and stunted (n = 520). The children were randomly assigned to receive either control rice (CR) or BFR provided in cooked portions to their households daily, with compliance monitoring. The primary outcome was PZC. Secondary outcomes were zinc deficiency, linear growth, infection-related morbidity, FADS activity indices, intestinal fatty acid binding protein (I-FABP) and fecal calprotectin. We applied sparse serial sampling for midpoint measures and analyzed data by intention-to-treat using mixed-effects models.ResultsAt baseline, median (IQR) PZC was 60.4 (56.3-64.3) µg/dL, 78.1% of children were zinc deficient, and 59.7% were stunted. Mean ± SD daily zinc intakes from the CR and BFR during the trial were 1.20 ± 0.34 and 2.22 ± 0.47 mg/d, respectively (P < 0.001). There were no significant time-by-treatment effects on PZC, zinc deficiency prevalence, FADS activity, I-FABP, or fecal calprotectin (all P > 0.05). There was a time-treatment interaction for height-for-age z-scores (P < 0.001) favoring the BFR group. The morbidity longitudinal prevalence ratio was 1.08 (95% CI: 1.05, 1.12) comparing the BFR and CR groups, due to more upper respiratory tract illness in the BFR group.ConclusionsConsumption of BFR for 9 mo providing ∼1 mg of additional zinc daily to Bangladeshi children did not significantly affect PZC, prevalence of zinc deficiency, or FADS activity.The trial was registered at clinicaltrials.gov as NCT03079583.

Project description:BackgroundChild overweight prevalence is increasing globally, but micronutrient deficiencies persist.ObjectivesWe aimed to 1) describe the prevalence and distribution of intraindividual double burden of malnutrition (DBM), defined as coexistence of overweight or obesity (OWOB) and either micronutrient deficiencies or anemia, among preschool children; 2) assess the independence of DBM components, e.g., whether the prevalence of DBM is greater than what would be expected by chance; and 3) identify predictors of intraindividual DBM, to guide intervention targeting.MethodsWe analyzed data from 24 population-based surveys from the Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia project (separately by survey; n = 226 to n = 7166). We defined intraindividual DBM as coexisting OWOB and ≥1 micronutrient deficiency [e.g., Micronutrient Deficiency Index (MDI) > 0; DBM-MDI] or anemia (DBM-Anemia). We assessed independence of DBM components with the Rao-Scott chi-square test and examined predictors of DBM and its components with logistic regression.ResultsDBM prevalence ranged from 0% to 9.7% (median: 2.5%, DBM-MDI; 1.4%, DBM-Anemia), reflecting a lower prevalence of OWOB (range: 0%-19.5%) than of micronutrient deficiencies and anemia, which exceeded 20% in most surveys. OWOB was generally not significantly associated with micronutrient deficiencies or anemia. In more than half of surveys, children 6-23 mo of age, compared with ≥24 mo, had greater adjusted odds of DBM-Anemia, anemia, and micronutrient deficiencies. Child sex and household socioeconomic status, urban location, and caregiver education did not consistently predict DBM or its components.ConclusionsIntraindividual DBM among preschool children was low but might increase as child OWOB increases. The analysis does not support the hypothesis that DBM components cluster within individuals, suggesting that population-level DBM may be addressed by programs to reduce DBM components without targeting individuals with DBM.

Project description:BACKGROUND:Although the use of micronutrient powders (MNPs) is considered the preferred approach for childhood anemia control, concerns about iron-related morbidity from clinical trials have challenged programmatic scale-up. OBJECTIVE:We aimed to measure the effects of community-based sales of MNPs on diarrhea-, fever-, cough-, and malaria-morbidity episodes in children 6-35 mo of age. DESIGN:We conducted a cluster-randomized trial in rural Western Kenya where 60 villages were randomly assigned to either intervention or control groups. MNPs (containing iron, vitamin A, zinc, and 11 other micronutrients) and other health products (e.g., insecticide-treated bednets, soap, and water disinfectant) were marketed in 30 intervention villages from June 2007 to March 2008. Household visits every 2 wk were used to monitor self-reported MNP use and morbidity (illness episodes in the previous 24 h and hospitalizations in the previous 2 wk) in both groups. Iron, vitamin A, anemia, malaria, and anthropometric measures were assessed at baseline and at 12 mo of follow-up. Data were analyzed by intent-to-treat analyses. RESULTS:Of 1062 children enrolled in the study, 1038 children (97.7%) were followed (a total of 14,204 surveillance visits). Mean MNP intake in intervention villages was 0.9 sachets/wk. Children in intervention villages, compared with children in control villages, had ~60% fewer hospitalizations for diarrhea (0.9% compared with 2.4%, respectively; P = 0.03) and 70% fewer hospitalizations for fever (1.8% compared with 5.3%, respectively; P = 0.003) but no significant differences in hospitalizations for respiratory illness (1.1% compared with 2.2%, respectively; P = 0.11) or malaria (3.1% compared with 2.9%, respectively; P = 0.82). There were no differences between groups in the numbers of episodes of diarrhea, cough, or fever. CONCLUSIONS:MNP use in Western Kenya through market-based community sales was not associated with increased infectious morbidity in young children and was associated with decreased hospitalizations for diarrhea and fever. An integrated distribution of MNPs with other health interventions should be explored further in settings with a high child malnutrition and infection burden. This trial was registered at clinicaltrials.gov as NCT01088958.

Project description:A new variety of zinc biofortified wheat (Zincol-2016) was released in Pakistan in 2016. The primary aim of this study was to examine the effects of consuming Zincol-2016 wheat flour on biochemical and functional markers of zinc status in a population with widespread zinc deficiency. An individually-randomised, double-blind, placebo-controlled cross over design was used. Fifty households were recruited to participate in the study, with each household included at least one woman of reproductive age (16-49 years) who was neither pregnant nor breast feeding or currently taking nutritional supplements. All households were provided with control flour for an initial 2-week baseline period, followed by the intervention period where households were randomly allocated in a 1:1 ratio to receive biofortified flour (group A; n = 25) and control flour (group B; n = 25) for 8-weeks, then switched to the alternate flour for 8-weeks. The trial has been registered with the ISRCTN (https://www.isrctn.com), ID ISRCTN83678069. The primary outcome measure was plasma zinc concentration, and the secondary outcome measures were plasma selenium and copper concentrations, plasma copper:zinc ratio and fatty acid desaturase and elongase activity indices. Nutrient intake was assessed using 24-h dietary recall interviews. Mineral concentrations in plasma were measured using inductively coupled plasma mass spectrometry and free fatty acids and sphingolipids by mass spectrometry. Linear Mixed Model regression and General Linear Model with repeated measures were used to analyse the outcomes. Based on an average flour consumption of 224 g/day, Zincol-2016 flour provided an additional daily zinc intake of between 3.0 and 6.0 mg for white and whole grain flour, respectively. No serious adverse events were reported. This resulted in significant, increase in plasma zinc concentration after 4 weeks [mean difference 41.5 μg/L, 95% CI (6.9-76.1), p = 0.02]. This was not present after 8 weeks (p = 0.6). There were no consistent significant effects of the intervention on fatty acid desaturase and elongase activity indices. Regular consumption of Zincol-2016 flour increased the daily zinc intake of women of reproductive age by 30-60%, however this was not associated with a sustained improvement in indices of zinc status.

Project description:Wheat (Triticum aestivum L.) is one of the major staples in Nepal providing the bulk of food calories and at least 30% of Fe and Zn intake and 20% of dietary energy and protein consumption; thus, it is essential to improve its nutritional quality. To select high-yielding genotypes with elevated grain zinc and iron concentration, the sixth, seventh, eighth, and ninth HarvestPlus Yield Trials (HPYTs) were conducted across diverse locations in Nepal for four consecutive years: 2015-16, 2016-17, 2017-18, and 2018-19, using 47 biofortified and 3 non-biofortified CIMMYT-bred, bread wheat genotypes: Baj#1, Kachu#1, and WK1204 (local check). Genotypic and spatial variations were found in agro-morphological traits; grain yield and its components; and the grain zinc and iron concentration of tested genotypes. Grain zinc concentration was highest in Khumaltar and lowest in Kabre. Likewise, grain iron concentration was highest in Doti and lowest in Surkhet. Most of the biofortified genotypes were superior for grain yield and for grain zinc and iron concentration to the non-biofortified checks. Combined analyses across environments showed moderate to high heritability for both Zn (0.48-0.81) and Fe (0.46-0.79) except a low heritability for Fe observed for 7th HPYT (0.15). Grain yield was positively correlated with the number of tillers per m2, while negatively correlated with days to heading and maturity, grain iron, grain weight per spike, and thousand grain weight. The grain zinc and iron concentration were positively correlated, suggesting that the simultaneous improvement of both micronutrients is possible through wheat breeding. Extensive testing of CIMMYT derived high Zn wheat lines in Nepal led to the release of five biofortified wheat varieties in 2020 with superior yield, better disease resistance, and 30-40% increased grain Zn and adaptable to a range of wheat growing regions in the country - from the hotter lowland, or Terai, regions to the dry mid- and high-elevation areas.

Project description:BackgroundMultiple micronutrient deficiencies are highly prevalent among preschool children and often lead to anemia and growth faltering. Given the limited success of supplementation and health education programs, fortification of foods could be a viable and sustainable option. We report results from a community based double-masked, randomized trial among children 1-4 years evaluating the effects of micronutrients (especially of zinc and iron) delivered through fortified milk on growth, anemia and iron status markers as part of a four group study design, running two studies simultaneously.Methods and findingsEnrolled children (n = 633) were randomly allocated to receive either micronutrients fortified milk (MN = 316) or control milk (Co = 317). Intervention of MN milk provided additional 7.8 mg zinc, 9.6 mg iron, 4.2 microg selenium, 0.27 mg copper, 156 microg vitamin A, 40.2 mg vitamin C, and 7.5 mg vitamin E per day (three serves) for one year. Anthropometry was recorded at baseline, mid- and end-study. Hematological parameters were estimated at baseline and end-study. Both groups were comparable at baseline. Compliance was over 85% and did not vary between groups. Compared to children consuming Co milk, children consuming MN milk showed significant improvement in weight gain (difference of mean: 0.21 kg/year; 95% confidence interval [CI] 0.12 to 0.31, p<0.001) and height gain (difference of mean: 0.51 cm/year; 95% CI 0.27 to 0.75, p<0.001). Mean hemoglobin (Hb) (difference of 13.6 g/L; 95% CI 11.1 to 16.0, p<0.001) and serum ferritin levels (difference of 7.9 microg/L; 95% CI 5.4 to 10.5, p<0.001) also improved. Children in MN group had 88% (odds ratio = 0.12, 95% CI 0.08 to 0.20, p<0.001) lower risk of iron deficiency anemia.Conclusions/significanceMilk provides an acceptable and effective vehicle for delivery of specific micronutrients, especially zinc and iron. Micronutrient bundle improved growth and iron status and reduced anemia in children 1-4 years old.

Dataset Information

Efficacy of high zinc biofortified wheat in improvement of micronutrient status, and prevention of morbidity among preschool children and women - a double masked, randomized, controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Efficacy of high zinc biofortified wheat in improvement of micronutrient status, and prevention of morbidity among preschool children and women - a double masked, randomized, controlled trial.

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