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CompletedNCT04404751Updated Feb 23, 2021

Quadruple Fortified Salt Clinical Trial

An interventional study of Iodised salt with Iron, Folic acid and Vitamin B12 in Anemia, sponsored by Haydom Lutheran Hospital. Completed at 1 site in Tanzania. Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by Haydom Lutheran Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
174
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Anemia
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Planning to become pregnant within the study period,
  • chronically ill,
  • have haematological diseases during study time,
  • restricted to use salt in food
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
174 participants (actual)

Study arms

  • Active comparator
    Arm 1

    Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

  • Active comparator
    Arm 2

    Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

  • Sham comparator
    Arm 3

    Combination Product: Iodised salt with Iron, Folic acid and Vitamin B12

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

    Also known as: Iodised salt with Iron

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 10 months of consuming fortified salt

Secondary outcomes

  1. Iron store replenishment

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

    Time frame: 10months of intervention

06

Study locations

1 site
  • Haydom Lutheran Hospital
    Manyara, Tanzania
07

Registry details

Key details

Study ID
NCT04404751
Lead sponsor
Haydom Lutheran Hospital
Collaborators
University of Toronto, Tanzania Food and Drugs Authority
Responsible party
Sponsor
First posted
May 27, 2020
Start date
Aug 23, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Feb 23, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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