Skip to main content
OpenTrials
Completed

NCT Number: NCT04404751

Quadruple Fortified Salt Clinical Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydom Lutheran Hospital

Manyara, Tanzania

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodised salt with Iron, Folic acid and Vitamin B12

Combination Product

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 names: Iodised salt with Iron

Primary outcomes

  1. Haemoglobin level

    Time frame: 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 outcomes

  1. Iron store replenishment

    Time frame: 10months of intervention

    The quadruple fortified salt is expected to replenish the iron store 100% after 10 months use of QFS

Sponsors and collaborators

Lead sponsor

Haydom Lutheran Hospital

Other

Collaborators

  • Tanzania Food and Drugs Authority
  • University of Toronto

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 27, 2020
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.