Quadruple Fortified Salt Clinical Trial

NCT04404751 | Completed DMC

• 1 other identifier: Salt_HGHRC#01
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

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

  10 months of consuming fortified salt

Secondary Outcomes (1)

• Iron store replenishment

  10months of intervention

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

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

Arm 2

ACTIVE COMPARATOR

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

Arm 3

SHAM COMPARATOR

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

Interventions

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

Also known as: Iodised salt with Iron

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult with relative low haemoglobin (Hb level 8g/dl to 13g/dl)
• Able to eat food cooked with salt
• Able to give consent

You may not qualify if:

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

Sponsors & Collaborators

• Haydom Lutheran Hospital: lead
• University of Toronto: collaborator
• Tanzania Food and Drugs Authority: collaborator

Study Sites (1)

Haydom Lutheran Hospital

Manyara, Tanzania

Location

MeSH Terms

Conditions

Anemia

Interventions

iodized salt; Iron; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: May 27, 2020
• Study Start: August 23, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 23, 2021

Record last verified: 2020-05

Locations

TA (1)