Quadruple Fortified Salt Clinical Trial

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04404751
• Other study ID #: Salt_HGHRC#01
• Status: Completed
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Haydom Lutheran Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Combination Product:
• Iodised salt with Iron, Folic acid and Vitamin B12
Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt

Locations

Country	Name	City	State
Tanzania	Haydom Lutheran Hospital	Manyara

Sponsors (3)

Lead Sponsor	Collaborator
Haydom Lutheran Hospital	Tanzania Food and Drugs Authority, University of Toronto

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Iron store replenishment	The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS	10months of intervention