RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Prevalence of goitre and iodine deficiency among school children (6-12 years) in rural areas of North Karnataka, India: A cross-sectional survey, 2016-19.

Introduction: Iodine deficiency disorders (IDD) have remained an unresolved public health problem in India. In this survey, we have estimated the prevalence of IDD among 6-12 years of school children in rural areas of north Karnataka, India and estimated the prevalence of low iodine content (<15 ppm) in salt at the household level and urine iodine excretion in this population. Material and Methods: In this cross-sectional survey, we recruited 16,827 children between 6 and 12 years of age through multistage sampling from six districts. Goitre was examined clinically for all children. Household-level salt iodine estimation and urinary iodine estimation were carried out among a subset of the participants. Results: Overall prevalence of goitre was 17.1% (95% CI: 16.5, 17.7). Out of this, 76.7% (n = 2116) had Grade-1 goitre, and 23.7% (n = 656) had Grade-2 goitre. The prevalence of goitre was higher among females (17.9%, vs. male 16.4%, P < 0.05). The prevalence of low iodine content (<15 ppm) in salt was 48.5% (95%CI: 46.7, 50.3). The overall median iodine excretion in urine was 85 µg/L (IQR: 60-150 µg/L). In total, 37.2% (n = 601) had mild iodine deficiency, 5.2% (n = 84) had moderate deficiency, and 10.1% (n = 163) had severe deficiency. All parameters showed high inter- and intradistrict variations. Conclusion: North Karnataka has a high goitre prevalence. Low use of iodized salt can be a major reason for the high prevalence of the condition. Ensuring the availability of iodized salt in this region and periodic surveillance to measure the impact of the programme should be the priority in this region.

Impact of a school-based nutrition educational intervention on knowledge related to iron deficiency anaemia in rural Karnataka, India: A mixed methods pre-post interventional study.

OBJECTIVE: To understand the extent to which adolescent awareness about anaemia and anaemia prevention can be changed by nutrition messages received at school. DESIGN: Mixed-methods pre-post intervention study. SETTING: Three government schools in Bagalkot, Belagavi and Raichur districts of Karnataka, India. POPULATION: Students of grade six and seven and teachers involved in implementing the intervention. METHODS: An educational intervention was co-developed by school teachers and nutrition experts using locally adapted resource materials that consisted of lectures, role play and practical demonstrations. Seven half-hour educational sessions were delivered by school teachers over 7 weeks to 455 students. Pre- and post-intervention tests measured changes in adolescents' knowledge about anaemia. Semi-structured in-depth interviews with teachers and focus groups with students explored their reactions to the intervention. MAIN OUTCOME MEASURES: Knowledge score related to anaemia. RESULTS: The percentage of children with correct scores increased by 7.3-49.0 percentage points for the tested questions after implementation of the intervention. The mean knowledge score increased by 3.67 ± 0.17 (p < 0.01). During interviews, teachers and students highlighted high acceptance of the intervention and materials, an increase in awareness, a positive attitude towards changing behaviour around diet, an increase in the demand for iron and folic acid supplements and improved sharing of messages learned with peers and families. Challenges expressed included need for further training, time limitations and hesitancy in teaching about menstruation and pregnancy. CONCLUSIONS: Educational interventions carried out for adolescents by teachers in schools are effective in improving awareness and attitude related to anaemia and its prevention.

Undernutrition among rural school-age children: a major public health challenge for an aspirational district in Karnataka, India.

Background: For school-age children, a healthy transition from childhood to adolescence and adulthood depends on proper nutrition. Globally, most nutritional surveys focus on preschool and adolescents, neglecting school-age children. Recent studies have shown the prevalence of thinness among adolescents to be 26.5% in Karnataka. Similarly, among children aged < 5 years in the Raichur district, the prevalence of stunting, wasting, and being underweight was 39.8, 23.2, and 40.7%, respectively. The present study aimed to bridge the data gap between < 5 years of children and adolescents through a nutritional survey of school-going children in Raichur, one of the aspirational districts of India. Materials and methods: A cross-sectional survey was conducted from January to March 2020 among rural school-age children (n = 2700) in 30 villages of the Raichur district of Karnataka, India. The school children were selected through a multi-stage cluster sampling technique. The WHO Anthro-plus software was used for calculating the age and sex-specific Z-scores for weight-for-age (WAZ), height-for-age (HAZ), and BMI-for-age (BAZ). Results: Of the 2,700 school-age children surveyed, the mean weight and height were 22.2 kg (+5.8) and 124.9 cm (+11.6), respectively. The prevalence of children having weight-for-age Z-scores < -2 SD (Underweight) was 45.3% (95% CI: 42.7%-47.8%). The magnitude of stunting and severe stunting was 19.5% (95% CI: 18.0%-21.0%) and 7.6% (95% CI: 6.6%-8.6%), respectively. The proportion of children with BMI for age Z-scores < -2SD (thinness) was 43% (95% CI: 41.1%-44.9%), with sub-district Sindhanur having a dual burden of malnutrition. Conclusion: Despite many flagship programs, the prevalence of undernutrition in school-age children remains a considerable public health problem in the aspirational district of Raichur, India. Furthermore, exploratory studies are recommended to identify the factors associated with undernutrition among school-age children and strategize evidence-based intervention.

A community-based study of dental fluorosis in rural children (6-12 years) from an aspirational district in Karnataka, India.

Objectives: The present study was planned to estimate the prevalence of dental fluorosis in 6-12 years of children and its association with various drinking water sources, water, and urine fluoride levels among the subset of children under the umbrella of a larger study to address iodine deficiency disorders and iron deficiency anemia in 17 villages of Manvi and Devadurga talukas of Raichur district of Karnataka. Methods: Analysis of subset of data and urine samples of children under the umbrella of a larger cross-sectional community-based study was conducted in 17 villages of Manvi and Devadurga taluks of Raichur district. House to house survey was carried out to collect data using a semi-structured questionnaire in ODK software. Demographic details, source of drinking water, clinical assessment of dental fluorosis, and height and weight measurements were performed by trained staff. Urine and water samples were collected for fluoride level estimation. The overall prevalence of dental fluorosis and its severity-wise prevalence were estimated. Association between dental fluorosis and age, gender, type of diet, source of drinking water, height for age, BMI for age, water fluoride level, and urine fluoride level were carried out using logistic regression analysis. Results: The prevalence of dental fluorosis was 46.0%. Mild, moderate, and severe dental fluorosis was found in 37.9, 7.8, and 0.3% of children. With the increasing age of participants, the odds of dental fluorosis were found to increase by 2-4 folds. The odds of having dental fluorosis were significantly increased with increasing water fluoride levels of 3 to 5 ppm [AOR = 3.147 (1.585-6.248); P = 0.001] in comparison with water fluoride levels of < 1 ppm. The similar trend was found with urine fluoride level > 4 ppm [AOR = 3.607 (1.861-6.990); P < 0.001]. As compared to river water, other sources of drinking water were significantly associated with higher odds of dental fluorosis. Conclusions: Prevalence of dental fluorosis was high in 6 to 12 years due to overexposure of fluoride from drinking water. High water and urine fluoride levels in children indicate the chronic exposure to fluoride and suggest that the population is at high risk of developing chronic fluorosis.

Attention for and awareness of anemia in adolescents in Karnataka, India: A qualitative study.

Between 1990 and 2016 the number of adolescents with anemia world-wide increased by 20% to almost one in four. Iron deficiency in adolescence results in compromised growth, decreased cognitive function, and depressed immune function, and can increase the risk of negative outcomes in pregnancy, especially in the case of young adolescents. In India, despite several decades of governmental investment in anemia prevention and treatment, more than half of women of reproductive age are anemic, with rates even higher in the adolescent population. Although awareness of adolescence as a nutrition-sensitive developmental stage is increasing, there is a lack of qualitative research on the perspectives of adolescents and families on anemia and related services. In this study, we explored the issues influencing adolescents' awareness of anemia in three rural areas of Karnataka. Sixty-four in-depth interviews and six focus group discussions were conducted with adolescents (those who had never been pregnant, pregnant adolescents, and young mothers), community members, and nutrition-related service providers in the health and education sectors. An inductive analytical approach was used. We found that adolescent girls, particularly those who have not experienced pregnancy or motherhood, had very low awareness of anemia. State programs including school-based distribution of iron and folic acid supplements and nutrition talks were not seen to be resulting in knowledge and acceptance of the importance of preventing anemia. Pregnancy represents a turning point in which adolescents are systematically tested for anemia as part of routine antenatal care, increasing their awareness of, and access to, treatment for the condition. At the same time, pregnancy represents to family and community a period to insist on a nutritious diet. For progress in anemia reduction to be made, improved age-appropriate measures specific for adolescence are required. Improving school-based nutrition outreach is an important opportunity to reach adolescents.