Quadruple Fortified Salt Clinical Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04404751

Enrollment

174

Registered

2020-05-27

Start date

2019-08-23

Completion date

2020-12-31

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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

Interventions

COMBINATION_PRODUCTIodised 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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 49 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026