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Effect of salt fortified with vitamins and minerals among women

Study of Multiply-Fortified Salt Among Women of Reproductive Age in India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040333
Enrollment
780
Registered
2022-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Quintuply fortified salt (Arms 1 and 2): Arm 1: Qunituply-fortified salt with iron in the form of ferric pyrophosphate (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyr
zinc in the form of zinc oxide (at 1.4 mg of zinc per gram of salt)
vitamin B12 (at 0.6 ug of vitamin B12 per gram of salt)
folic acid (at 52.4 ug folic acid per gram of salt), iodine (at 30 ug of iodine per gram of salt). Mean intake of discretionary salt in the study population is 4.6 grams per day.Therefore, the FePP-Q
folic acid (at 52.4 ug folic acid per gram of salt), iodine (at 30 ug of iodine per gram of salt) Mean intake of discretionary salt in the study population is 4.6 grams per day.Therefore, the eFF-Q5

Sponsors

Dr Christine McDonald
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) 18-49 years of age; 2) Not currently pregnant (self-reported); 3) Not severely anemia (defined as a hemoglobin concentration 4) Not planning to become pregnant within the next year; 5) 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; 6) No serious health problems that requires regular visits to a health facility; 7) Willingness to use refined salt provided by the study as a primary source of household discretionary salt.

Exclusion criteria

Exclusion criteria: 1) Age is less than 18 or more than 49 years; 2) Pregnant at the time of enrolment(self-report) or planing to became pregnant within the next year; 3) Severely anemia (i.e. hemoglobin concentration 4) Not a permanent resident of the study area; 5) Planning to leave the study area for at least one month over the study period; 6) Serious health problem that interferes with eating practices and/or requires hospitalization; 7) Unwilling to use refined salt provided by the study as a primary source of household discretionary salt.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 24 Months from the start of enrolment

Secondary

MeasureTime frame
Change in the abundance and diversity of the gut microbiome Timepoint: 24 Months from the start of enrolment

Countries

India

Contacts

Public ContactDr Reena Das

Post Graduate Institute of Medical Education and Research Chandigarh

reenadaspgi@hotmail.com07087008128

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026