Quadruple Fortified Salt Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12<br>* Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt<br>* Other names: Iodised salt with Iron;|
| Active Comparator: Arm 2<br> | Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12<br>* Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt<br>* Other names: Iodised salt with Iron;|
| Sham Comparator: Arm 3<br> | Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12<br>* Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt<br>* Other names: Iodised salt with Iron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin level | 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 | 10 months of consuming fortified salt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron store replenishment | The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS | 10months of intervention |