Quadruple Fortified Salt Clinical Trial

Not Applicable

Completed

• Conditions: Anemia

• Registration Number: NCT04404751
• Lead Sponsor: Haydom Lutheran Hospital

Brief 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.

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

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-09-03
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-27
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-02-21
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Iron store replenishment	10months of intervention	The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS

Trial Locations

Locations (1)

Haydom Lutheran Hospital; 🇹🇿 Manyara, Tanzania