Quadruple Fortified Salt Clinical Trial

NCT04404751 — Not applicable, Completed, 174 participants, Haydom Lutheran Hospital

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Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting

Registry	NCT04404751
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: triple, treatment
Enrollment	174 (Actual)
Sponsor	Haydom Lutheran Hospital (Other); collaborators: University of Toronto, Tanzania Food and Drugs Authority
Conditions	Anemia
Interventions	Iodised salt with Iron, Folic acid and Vitamin B12 (Combination product)
Dates	start 2019-08-23, primary completion 2020-12-31, completion 2020-12-31, first posted 2020-05-27, last updated 2021-02-23
Locations	1 site in Tanzania

-Summary

Anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa and Asia. Despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. With these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.

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+Detailed description

Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed anaemic if has HB <11g/dl but in high attitude is =<13g/dl

+Arms and interventions

Arm	Type	Interventions
Arm 1	Active comparator	Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12
Arm 2	Active comparator	Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12
Arm 3	Sham comparator	Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

Iodised salt with Iron, Folic acid and Vitamin B12 (Combination product), also known as Iodised salt with Iron: Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt

+Outcome measures

Primary outcomes

Haemoglobin level [10 months of consuming fortified salt]: After 10months use of quadruple fortified salt we expect the HB to rise by at least 50% as compared to those who used iodised salt

Secondary outcomes

Iron store replenishment [10months of intervention]: The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS

+Eligibility

Sex: All, ages: 18 Years to 49 Years

Inclusion Criteria:

* Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)
* Able to eat food cooked with salt
* Able to give consent

Exclusion Criteria:

* Planning to become pregnant within the study period,
* chronically ill,
* have haematological diseases during study time,
* restricted to use salt in food

+Locations (1)

Facility	City	Country	Status
Haydom Lutheran Hospital	Manyara	Tanzania

My Notes

Public

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