Quadruple Fortified Salt Clinical Trial

February 21, 2021 updated by: Haydom Lutheran Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Manyara, Tanzania
        • Haydom Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
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
Other Names:
  • Iodised salt with Iron
Active Comparator: Arm 1
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
Other Names:
  • Iodised salt with Iron
Sham Comparator: Arm 3
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
Other Names:
  • Iodised salt with Iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 months of consuming fortified salt

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haydom Lutheran Hospital

Collaborators

University of Toronto
Tanzania Food and Drugs Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Salt_HGHRC#01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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