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

Quadruple Fortified Salt Clinical Trial

Sponsors

Lead sponsor: Haydom Lutheran Hospital

Collaborator: University of Toronto
Tanzania Food and Drugs Authority

Source 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

Overall Status Recruiting
Start Date August 23, 2019
Completion Date November 30, 2020
Primary Completion Date May 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Haemoglobin level 10 months of consuming fortified salt
Secondary Outcome
Measure Time Frame
Iron store replenishment 10months of intervention
Enrollment 174
Condition
Intervention

Intervention type: Combination Product

Intervention name: Iodised salt with Iron, Folic acid and Vitamin B12

Description: Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt

Other name: Iodised salt with Iron

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 49 Years

Healthy volunteers: No

Overall Contact

Last name: Paschal Mdoe, PhD

Phone: +255754429346

Email: [email protected]

Location
facility status contact contact_backup Haydom Lutheran Hospital Pascal Mdoe, MMed +255754429346 [email protected]
Location Countries

Tanzania

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: Arm 1

Arm group type: Active Comparator

Arm group label: Arm 2

Arm group type: Active Comparator

Arm group label: Arm 3

Arm group type: Sham Comparator

Study Design Info

Allocation: Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov