Quadruple Fortified Salt Clinical Trial

Haydom Lutheran Hospital

Status: Completed

Conditions: Anemia

Treatments: Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

Study type: Interventional

Funder types: Other

Identifiers

NCT04404751

Salt_HGHRC#01

Details and patient eligibility

About

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.

Full 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

Enrollment: 174 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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174 participants in 3 patient groups

Arm 1

Active Comparator group

Treatment:

Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

Arm 2

Active Comparator group

Treatment:

Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

Arm 3

Sham Comparator group

Treatment:

Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12