Institutions Involved Institutions Involved Center for Micronutrient Research, Subharti Medical College, UP Center for Micronutrient Research, Subharti Medical College, UP Center for Public Health Kinetics, Delhi Center for Public Health Kinetics, Delhi Field Sites Sangam Vihar and Harsh Vihar, Delhi
Background and Rationale Worldwide, two billion people are at risk of micronutrient deficiencies especially of iron and zinc deficiencies, particularly in regions with predominantly cereal-based diets. Zinc deficiency is an important cause of mortality and morbidity due to infectious diseases and growth faltering among children and adverse pregnancy outcomes among women of reproductive age (WRA). Zinc supplementation has been proven to be beneficial effective in reducing morbidity and improving growth, given zinc supplementation needs to be given daily is not feasible as a program thus, other sustainable methods such as food based intervention to increase zinc intakes need to be explored and evaluated. Bio-fortification of staple food crops with zinc can be a cost-effective and sustainable strategy in eradicating zinc deficiency and in improving the zinc/iron status and physical growth of the target population. However, there is lack of scientific evidence from randomized controlled trials for its efficacy.
Objectives of the study In a randomized controlled trial, to evaluate the effects of the consumption of high zinc biofortified wheat (HZn) in comparison to nonbiofortified wheat flour (LZn) on: Zinc and iron status Prevention of childhood diarrheal and non-diarrheal morbidity Physical growth Compliance to wheat flour (zinc biofortified wheat flour and control wheat flour)
Study Description Setting: Community Study Design: Randomized controlled study Study Population: Peri-urban Population Study Sites: Sangam Vihar (a resettlement colony-south Delhi) and Harsh Vihar (semi-urban locality-north East Delhi) Interventions: Zinc biofortified wheat flour and regular wheat flour Randomization: Household level (subjects in same household will receive the same intervention), by permuted block size of 12 Computer generated table Intervention Delivery: -WRA- 360 g of ration daily Follow-up: 6 months -Children (aged 4-6 yrs) -120 g ration daily
Total Sample Size : 6000 Women of Reproductive Age (not pregnant or lactating) -3000 Children (4-6 years of Age) -3000 Intervention Groups Group 1: Zinc Biofortified Wheat Flour [Wheat used for bio-fortification was a commercial variety of wheat (PBW 550), grown in agronomic conditions & zinc content enhanced by foliar spraying of zinc sulfate fertilizer] Group 2: Non-Fortified or Regular Wheat Flour
Eligibility Criteria In the same household, women of reproductive age and child aged 4-6 years can be enrolled. Preschool children: Between 4-6 years of age; not severely malnourished requiring rehabilitation; consent to participate; likely to live in the study area for at least 6 months, their staple diet is wheat. Women of child-bearing age: Between 15-49 years of age (non-lactating and non pregnant), not having any severe illnesses requiring hospitalization; consent to participate; permanent residents or willing to stay in this study area for next six months, their staple diet is wheat.
Study Procedures: Baseline Survey conducted to identify all eligible subjects (WRA and Children). Eligible subjects were consented, screened in study clinic and if found eligible were enrolled and randomized to one of the intervention groups (Members from same household were randomized in the same intervention group). Baseline data included physical examination, anthropometric (Ht, Wt, Waist Circumference for WRA) measurement and wheat consumption pattern and usage. 5 ml venous blood was obtained for assessment of baseline biomarkers (zinc, CBC, Serum Ferritin, acute phase markers-crp and AGP).
Study Procedures Contd. Intervention supplies for next 15 days were provided throughout the study duration (each family were given there allocated wheat group during the whole study period), a pictorial diary card was used to record compliance. Subjects were advised to consume 120g (aged 4-6 years) or 360g (aged 15-49 years) of assigned wheat flour daily. Additional wheat flour (i.e. regular flour @200g daily per household) were given to families to avoid sharing with other family members. Enrolled families were followed up weekly at home by a team of health workers to record morbidity/mortality and compliance information, if found sick were referred to study clinic for a detailed morbidity assessment by the study physician.
Study Procedures Contd. In addition, spot checks were carried out to assess the food availability in the home. Dietary intake data were collected using interactive 24-hour dietary recall and semi-quantitative food frequency questionnaire (SFFQ) to estimate the macro- or micro-nutrient intake. At the end of six months of intervention, subjects were again assessed for morbidity, anthropometric measurements (weight, height, Waist circumference-only in WRA) and 5 ml venous blood sample was obtained for assessment post supplementation bio-marker status (zinc, CBC, Serum Ferritin, acute phase markers-crp and AGP).
Baseline SES Characteristics of the Study Population Type of Family HZn (n=2997) LZn (n=3008) Type of House Nuclear 83.1% 80.9% Pucca 27.8% 26.2% Kaccha Pucca 71.3% 73.3% Kaccha 0.9% 0.5% Owns House 52.9% 56.3% Wealth Quintile 2.98±1.42 3.01±1.42
Anthropometric Characteristics of Children at baseline and endstudy Baseline Endline HZn (n=1308) LZn (n=1312) Weight 15.88±4.15 15.85±4.64 Height 104.6±9.08 104.3±8.9 WAZ -1.56±1.03-1.56±0.99 HAZ -1.56±1.22-1.60±1.17 Weight 17.85±40.39 16.60±3.05 Height 108.6±8.9 109.4±35.6 WAZ -1.54±1.07-1.56±0.99 HAZ -1.35±1.15-1.40±1.11
Difference in Z-scores of Anthropometric indices among Children HZn (n=1308) LZn (n=1312) Diff in mean 95 % CI Difference in z scores WAZ 0.02±0.46 0.0008±0.39 0.02-0.01,0.05 HAZ 0.21±0.29 0.20±0.29 0.01-0.01,0.03
Plasma Zinc Status (ug/dl) Baseline HZn (n=2877) LZn (n=2871) Mean±sd 56.2±13.6 56.6±13.4 Median 55.6 56.6 <60 1845 (64.3) 1756 (61.4) <70 2458 (85.6) 2466 (85.9) Endline (n=2537) (n=2533) Mean±sd 62.4±18.6 62.1±14.9 Median 61.3 61.8 <60 1170 (46.2) 1160 (45.9) <70 1841 (72.7) 1826 (72.3)
Effect of intervention on Morbidity indicators among Children HZn LZn RR 95 % CI Days with Diarrhea Days with pneumonia Days with fever Days with Vomiting Days with Ear Discharge 126 119 1.05 0.82-1.37 203 244 0.83 0.69-1.00 949 976 0.97 0.89-1.06 60 99 0.61 0.43-0.84 72 87 0.83 0.60-1.14
Effect of intervention on Morbidity indicator among women of Reproductive health HZn LZn RR 95 % CI Days with fever 999 1092 0.91 0.84-0.99
Zinc content of Wheat Flour provided for the trial at various time points during the study. HZn (n=2877) LZn (n=2871) Start of trial 31.45±3.6 (32.3) 19.95±0.40 (19.8) Mid Year 1 30.38±1.52 (30.2) 20.45±0.99 (20.45) Start of Year 2 30.75±1.37 (30.9) 23.35±1.24 (23.05) Mid year 2 32.8±4.60 (31.56) 21.12 ±2.98 (19.95) End Year 2 29.78±1.69 (29.75) 21.08±0.90 (20.7)
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