Effect of salt fortified with vitamins and minerals among preschool childre

Not Applicable

Registration Number: CTRI/2022/02/040332

Lead Sponsor: Dr Christine McDonald

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Child 12-59 months of age at the time of enrollment;

2. Childâ??s mother or primary female caregiver has been enrolled into the parent trial;

3. Not severely anemic (defined as a hemoglobin concentration less than 7 g/dL);

4. Childâ??s family is a permanent resident of the study village with no plans to move or travel outside the village for more than 4 weeks over the next 12 months;

5. No serious medical problems that interfere with the childâ??s eating practices;

6. Childâ??s mother or primary female caregiver is willing to use refined salt provided by the study as the primary source of the householdâ??s discretionary salt for the course of the study.

Exclusion Criteria

1. Child age less than 12 or more than 59 months of age;

2. Childâ??s mother has not been enrolled into the parent trial;

3. Severely anemic (i.e. hemoglobin concentration less than 7 g/dL);

4. Childâ??s family is not a permanent resident of the study village and or has plans to move or travel outside the village for more than 4 weeks over the next 12 months;

5. Serious health problem that interferes with the childâ??s eating practices;

6. Childâ??s mother or primary female caregiver is unwilling to use refined salt provided by the study as the primary sources of the householdâ??s discretionary salt for the course of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean concentrations of biomarkers of the following micronutrients and the corresponding change in the prevalence of each micronutrient deficiency: iron: serum ferritin and soluble transferrin receptor; anemia: hemoglobin; zinc: serum zinc, nail zinc; vitamin B12; serum vitamin B12, methylmalonic acid, and holo-transcobalamin; and plasma homocysteine; folate: red blood cell folate; iodine: serum thyroglobulin and urinary iodine. <br/ ><br>Timepoint: 24 Months from the start of enrolment <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Mean discretionary salt intake <br/ ><br> Change in the abundance and diversity of the gut microbiome <br/ ><br>Timepoint: 24 Months from the start of enrolment <br/ ><br>