Large –scale wheat flour folic acid fortification program increases plasma folate levels among women of reproductive age in urban Tanzania

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Study Justification:
– Tanzania has a widespread vitamin and mineral deficiency problem, including deficiencies of vitamin A, iron, folate, and zinc.
– Folate deficiency among women of reproductive age is associated with adverse health effects, including a higher risk of neural tube defects.
– Tanzania has implemented a food fortification program, but evidence on its effectiveness is limited.
– This study aimed to evaluate the effectiveness of Tanzania’s food fortification program by examining folate levels among women of reproductive age.
Study Highlights:
– Prospective cohort study with 600 non-pregnant women enrolled.
– Blood samples, dietary intake, and fortified foods consumption data collected at baseline, 6 months, and 12 months.
– Plasma folate levels determined using a competitive assay with folate binding protein.
– Significant improvements in plasma folate levels observed at 6 months and 12 months compared to baseline.
– Prevalence of folate deficiency decreased from 26.9% at baseline to 5% at 12 months.
– Increase in plasma folate associated with a decreased risk of folate deficiency at 12 months.
Study Recommendations:
– The findings support the effectiveness of the food fortification program in improving folate status among women of reproductive age.
– Continued implementation and monitoring of the food fortification program is recommended to sustain these improvements.
– Further research is needed to assess the long-term impact of the program on maternal and child health outcomes.
Key Role Players:
– Ministry of Health and Social Welfare
– Tanzania Food and Drug Authority (TFDA)
– Tanzania Food and Nutrition Centre (TFNC)
– Ministry of Industry and Trade
– Tanzania Bureau of Standards (TBS)
– Food producers (including wheat flour producers and vegetable oil refineries)
Cost Items for Planning Recommendations:
– Production capacity for fortified products (wheat flour and vegetable oil)
– Quality inspections by TFDA
– Monitoring and evaluation of the program
– Nutrition counseling and education for participants
– Research and data collection for program evaluation
Please note that the provided information is based on the given description and may not include all details from the original publication.

The strength of evidence for this abstract is 8 out of 10.
The evidence in the abstract is strong because it is based on a prospective cohort study with a sample size of 600 women. The study collected blood samples, dietary intake data, and fortified foods consumption data at multiple time points. The study used univariate and multivariate regression analysis to compare changes in plasma folate levels and assess the risk of folate deficiency. The study found significant improvements in folate status among women of reproductive age after the implementation of the food fortification program. To improve the evidence, the study could have included a control group for comparison and conducted a randomized controlled trial design.

There is widespread vitamin and mineral deficiency problem in Tanzania with known deficiencies of at least vitamin A, iron, folate and zinc, resulting in lasting negative consequences especially on maternal health, cognitive development and thus the nation’s economic potential. Folate deficiency is associated with significant adverse health effects among women of reproductive age, including a higher risk of neural tube defects. Several countries, including Tanzania, have implemented mandatory fortification of wheat and maize flour but evidence on the effectiveness of these programs in developing countries remains limited. We evaluated the effectiveness of Tanzania’s food fortification program by examining folate levels for women of reproductive age, 18–49 years. A prospective cohort study with 600 non-pregnant women enrolled concurrent with the initiation of food fortification and followed up for 1 year thereafter. Blood samples, dietary intake and fortified foods consumption data were collected at baseline, and at 6 and 12 months. Plasma folate levels were determined using a competitive assay with folate binding protein. Using univariate and multivariate linear regression, we compared the change in plasma folate levels at six and twelve months of the program from baseline. We also assessed the relative risk of folate deficiency during follow-up using log-binomial regression. The mean (±SE) pre–fortification plasma folate level for the women was 5.44-ng/ml (±2.30) at baseline. These levels improved significantly at six months [difference: 4.57ng/ml (±2.89)] and 12 months [difference: 4.27ng/ml (±4.18)]. Based on plasma folate cut-off level of 4 ng/ml, the prevalence of folate deficiency was 26.9% at baseline, and 5% at twelve months. One ng/ml increase in plasma folate from baseline was associated with a 25% decreased risk of folate deficiency at 12 months [(RR = 0.75; 95% CI = 0.67–0.85, P600kcals and <4500kcals. Venous blood specimens (about 4 ml) were collected in purple top tubes containing K2EDTA using standard venepuncture procedures, and samples were sent to the Africa Academy of Public Health (AAPH) laboratory within two hours of collection. Once in the laboratory, specimens were centrifuged at 3200 rpm for ten minutes to obtain plasma that was stored in a -20C freezer in 1 to 3ml vials. Laboratory scientists made sure that specimens were free from hemolysis, lipemia and icterus. Plasma folate assays were done using the Cobas e411 automated analyzer (Roche Diagnostics, Switzerland) as per manufacturer instructions. The machine was calibrated by lyophilized human plasma with folate. Adding 1.0 ml of distilled water carefully dissolved the contents of the calibrators. The calibrators were mixed carefully, avoiding foam formation. Aliquots of the reconstituted calibrators were transferred into empty vials and stored at -20°C till needed. Whenever required, a pair of calibrators were brought out and thawed before use at room temperature. Testing proceeded after successful calibration, with 250–300μl of each sample run in duplicate and average readings recorded. Negative and positive controls were used for quality assurance in each run. Controls were run individually at least once per 24 hours while the test was in use, once per new reagent kit and after each passed calibration. Printed results were certified by one laboratory personnel and reviewed by another one, before entered into a database. The normal range for the equipment is 1.5–20.0 ng/ml. We analysed change in mean plasma folate levels from baseline, to 6, and 12 months of follow-up. Mean (±SD) values of total energy intake (in calories/day), macronutrient proportions of the total calorie intake, as well as intake of fortified wheat-based foods (in servings/day) were calculated to estimate folic acid intake at baseline. We estimated the change in levels of these measures from baseline, and assessed statistical significance using a paired Student’s T-test. The concentrations suggested for defining folate deficiency based metabolic indicators range from 3–4 ng/ml [15,16,34]. This value is derived from data related to preventing anaemia and hyperhomocysteneinemia and the public significance of applying same cut-off in isolating folate deficiency in the context of NTDs is not fully understood[15,34]. Evidence suggests risk of NTD increases with folate insufficiency levels higher than ranges defining folate deficiency[34]. We dichotomized plasma folate levels based on the stringent threshold indicative of folate deficiency using a cut-off point of 4 ng/ml[15,16]. We fit univariate and multivariate binomial regression models to assess the degree to which each unit change in plasma folate led to a change in the risk of folate deficiency at six and twelve months, and obtained risk ratio estimates[35]. In multivariate models, we included potential confounders known to be associated with folic acid intake and/or plasma folate levels, or have been identified in regression models (p<0.2) to be significantly related to dietary intake of folic acid at baseline. Relative risks were adjusted for age (18 to <2 6, 26 to <36 and 36–49 years), years of formal education (0–7 years, 8–11 years and ≥12 years), occupation (business/professional, skilled formal, skilled informal, unskilled, unemployed), body mass index (<18.5, 18.5 to <25, 25 to <30, ≥30 kg/m2), household dietary diversity score (1–12), baseline intake of fortified wheat-based foods (servings per day), intake of vegetables and total energy intake (kcals/day).The number of household assets were computed from a simple count that included TV, radio, generator, fan, bike, car, couch, fridge, as well as access to electricity and potable water, allowing classification into 3 socioeconomic groups thus: 0–5, 6–8, and 9–10 [36]. Covariates with missing data were retained in the analysis using the missing indicator method[37].P-values were two-sided and significance was set at < 0.05. Final data set S2 File was compiled and all statistical analyses were conducted using SAS version 9.2 (SAS Institute Inc).

One potential innovation to improve access to maternal health is the implementation of large-scale wheat flour folic acid fortification programs. This innovation has been shown to increase plasma folate levels among women of reproductive age in urban Tanzania, which can have significant positive effects on maternal health. The Tanzania National Food Fortification Program mandates fortification of targeted staple foods including salt, edible oil, wheat, and maize flour. This program involves collaboration between various organizations, including the Ministry of Health and Social Welfare, Tanzania Food and Drug Authority, Tanzania Food and Nutrition Centre, Ministry of Industry and Trade, Tanzania Bureau of Standards, and food producers. Currently, 14 large-scale food producers participate in the program, including all ten of the country’s wheat flour producers and four large-scale vegetable oil refineries. The production capacity for fortified products among these industries is substantial, accounting for approximately 88% of the market share for wheat flour and 80% for vegetable oil. The program ensures that fortified products meet quality standards through regular inspections. The effectiveness of the food fortification program was evaluated through a prospective cohort study involving 600 non-pregnant women of reproductive age. Plasma folate levels were assessed at baseline, 6 months, and 12 months, and dietary intake data were collected using a validated semi-quantitative food frequency questionnaire. The study found that the mean plasma folate levels significantly improved at 6 months and 12 months compared to baseline. The prevalence of folate deficiency also decreased from 26.9% at baseline to 5% at 12 months. The study further demonstrated that an increase in plasma folate levels was associated with a decreased risk of folate deficiency at 12 months. This innovation of large-scale wheat flour folic acid fortification programs can be a valuable strategy to improve access to maternal health by addressing vitamin and mineral deficiencies that have negative consequences on maternal health and cognitive development.
AI Innovations Description
The recommendation to improve access to maternal health based on the study is to implement a large-scale wheat flour folic acid fortification program. This program aims to address the widespread vitamin and mineral deficiency problem in Tanzania, particularly deficiencies in vitamin A, iron, folate, and zinc, which have negative consequences on maternal health and cognitive development.

The study evaluated the effectiveness of Tanzania’s food fortification program by examining folate levels among women of reproductive age. The results showed that the program significantly improved plasma folate levels among the participants. The prevalence of folate deficiency decreased from 26.9% at baseline to 5% at twelve months. Additionally, an increase in plasma folate levels was associated with a decreased risk of folate deficiency.

The Tanzania National Food Fortification Program mandates fortification of targeted staple foods, including wheat and maize flour. The program is implemented through a partnership between Helen Keller International and various government agencies and food producers. Currently, 14 large-scale food producers participate in the program, covering a significant portion of the market share.

To implement the large-scale wheat flour folic acid fortification program, it is important to ensure compliance with the fortification standards set by the Tanzania Bureau of Standards. Regular inspections should be conducted to ensure the quality of fortified products at production points, in the market, and at ports of entry.

In conclusion, implementing a large-scale wheat flour folic acid fortification program can significantly improve access to maternal health by addressing folate deficiency among women of reproductive age. This program should be implemented in collaboration with government agencies, food producers, and other relevant stakeholders to ensure its effectiveness and sustainability.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Increase awareness: Implement a comprehensive public health campaign to raise awareness about the importance of maternal health and the availability of maternal health services. This can include community outreach programs, educational materials, and media campaigns.

2. Improve healthcare infrastructure: Invest in improving healthcare facilities, especially in rural areas where access to maternal health services is limited. This can include building new clinics, upgrading existing facilities, and ensuring the availability of essential medical equipment and supplies.

3. Train healthcare providers: Provide training and capacity-building programs for healthcare providers, including doctors, nurses, and midwives, to improve their skills in providing quality maternal healthcare. This can include training on prenatal care, childbirth, postnatal care, and emergency obstetric care.

4. Strengthen referral systems: Establish and strengthen referral systems between primary healthcare facilities and higher-level hospitals to ensure that pregnant women with complications can access appropriate care in a timely manner.

5. Provide financial support: Implement policies and programs to provide financial support to pregnant women, especially those from low-income backgrounds, to cover the costs of maternal healthcare services. This can include subsidies, health insurance schemes, and cash transfer programs.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could include the following steps:

1. Define indicators: Identify key indicators to measure the impact of the recommendations, such as the number of pregnant women accessing prenatal care, the number of deliveries attended by skilled birth attendants, and the maternal mortality rate.

2. Collect baseline data: Gather data on the current status of maternal health in the target population, including the number of pregnant women, the availability and quality of healthcare facilities, and the utilization of maternal health services.

3. Implement interventions: Implement the recommended interventions, such as awareness campaigns, infrastructure improvements, healthcare provider training, and financial support programs.

4. Monitor and evaluate: Continuously monitor and evaluate the implementation of the interventions, collecting data on the indicators defined in step 1. This can include conducting surveys, interviews, and medical record reviews.

5. Analyze data: Analyze the collected data to assess the impact of the interventions on the selected indicators. This can involve statistical analysis, such as comparing pre- and post-intervention data and conducting regression analyses.

6. Interpret results: Interpret the results of the data analysis to determine the effectiveness of the interventions in improving access to maternal health. This can include identifying trends, patterns, and correlations in the data.

7. Adjust interventions: Based on the results and findings, make any necessary adjustments to the interventions to further improve access to maternal health. This can include scaling up successful interventions, addressing any identified gaps or challenges, and refining strategies.

8. Repeat the process: Continuously repeat the monitoring, evaluation, and adjustment process to ensure the ongoing improvement of access to maternal health. This can involve conducting regular assessments and making iterative changes based on the findings.

By following this methodology, it is possible to simulate the impact of the recommendations on improving access to maternal health and make evidence-based decisions for further interventions.

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