Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, India
NCT Number: NCT05166980
Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is cost-effective, utilizes existing delivery systems, can deliver multiple MNs simultaneously, and does not require behavior change by the population. Salt is a particularly attractive vehicle for multiple MN fortification in India, as it is universally consumed in fairly consistent amounts; and 93% of households already use adequately iodized salt.
The overall goal of this study is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of FePP (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyrophosphate plus ethylenediaminetetraacetic acid as an enhancer of absorption; zinc in the form of zinc oxide; vitamin B12; folic acid; and iodine) vs. quintuply-fortified salt with iron in the form of eFF (eFF-Q5S i.e. salt fortified with iron in the form of encapsulated ferrous fumarate; zinc in the form of zinc oxide, vitamin B12, folic acid, and iodine) vs. iodized salt (IS) for the improvement of micronutrient status among nonpregnant WRA and preschool-aged children (12-59 months of age) in Punjab, India.
Enrolled women (and their affiliated households) will be randomized to receive 1 kg of their assigned study salt per month for 12 months, and will be instructed to use the study salt in place of their usual salt. Blood and urine samples will be collected from participant WRA and PSC at enrollment, 6 months and at the end of the 12-month intervention period. The change in the mean concentration of various MN biomarkers will be considered primary outcomes. Stool samples will also be collected from a subgroup of women and children to assess changes in the gut microbiome over the intervention period.
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Notify Me12 month–49 year
All sexes
Interventional
Not applicable
Chandigarh, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for women of reproductive age:
Exclusion criteria
for women of reproductive age:
Inclusion criteria
for preschool children:
Exclusion criteria
for preschool children:
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
Other names: Quintuply-fortified salt
Salt fortified with iodine
Other names: Salt fortified with iodine
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean serum ferritin concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean hemoglobin concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean soluble transferrin concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean red blood cell folate concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean plasma zinc concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum vitamin B12 concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean holo-transcobalamin concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean concentration of methylmalonic acid
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum folate concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean urinary iodine concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum thyroglobulin concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in mean fingernail zinc concentration
Time frame: Enrollment to 12 months (i.e. end of intervention period)
Change in the abundance of potentially beneficial microbiota in the gut
University of California, San Francisco
Other
Acronym: MFS
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