https://orcid.org/0000-0002-9401-3982
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Abstract
Background
Micronutrients (iron, iodine, vitamin B12 and folate) deficiency is prevalent globally affecting more than two billion people majority being from low- and middle-income countries. Women of reproductive age are in an increased risk of iron deficiency. About 29.4% of women aged 15–49 years worldwide are estimated to be affected by iron deficiency. Food fortification with micronutrients is important in addressing micronutrients deficiency.
Aim
To evaluate if the quadruple fortified with iodine, iron, vitamin B12, and folic acid (QFS), will be more effective in improving the hemoglobin level of women aged 18 to 49 years compared to the double fortified with iodine and iron (DFS) and iodized salt in rural Tanzania.
Methods
A double-blinded three-arm randomized controlled trial was conducted between July 2020 and December 2021 at the Haydom Lutheran Hospital catchment area. We randomized women aged 18–49 years with haemoglobin between 8 and 12 g/dl who were neither pregnant nor lactating into three groups 55 Iodized salts (IS), 57 Double fortified salt (DFS), and 57 quadruple fortified salt (QFS). The participants used study salt for 10 months.
Results
Over the ten months of use of study salts, the overall mean haemoglobin level of women was significantly higher in QFS by 0.43g/dl compared to IS. The ferritin levels were significantly higher in QFS and DFS by 9.60ng/mL and 9.09ng/mL, respectively, compared to IS. Vitamin B12 was insignificantly higher in QFS by 52.19pg/mL compared to DFS, and folate concentration were insignificantly higher in QFS by 7.57nmoL/L and 4.51nmoL/L compared to DFS and IS groups, respectively.
Conclusion
Salt fortification with iron, iodine, folate, and Vitamin B12 is feasible and has the potential to increase the serum ferritin, Vitamin B12 and folate levels with subsequent improvement of haemoglobin levels of individuals with relatively low haemoglobin.
ClinicalTrial.org Number
NCT04404751.
Data Sharing Statement
The data that support the findings of this study are available from the Haydom Lutheran Hospital through [email protected].
Ethical Approval and Consent to Participate
The clinical trial was approved by the Tanzania National Institute for Medical Research ethical review committee (NIMR), the Ministry of Health, community development, gender elderly and children (NIMR/HQ/R.8a/Vol. IX/2719), and the Tanzania Medicine and Medical Devices Authority (TMDA) (TZ19CT0009). These (NIMR and TMDA) are the only legal authorities in Tanzania with the mandate of reviewing, approve and oversee the conduct of clinical trials involving human subjects. The permission to conduct the research was also obtained from the local authority in the region and districts where the trial was conducted. The written informed consent was obtained from the head of the household and from the participating woman. The trial was registered on 27/05/2020 on ClinicalTrial.org (NCT04404751). All trial methods were performed in accordance with the relevant international and national guidelines and regulations including the declaration of Helsinki.
Acknowledgment
We acknowledge all women who took part in this study and the Neelkanth salt Limited for mixing the salt with extracts.
Author Contributions
All authors contributed to data analysis, drafting, or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.