Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India

Not Applicable

Completed

• Conditions: Nutrient Deficiency
• Interventions: Dietary Supplement: Mutiply-fortified salt; Dietary Supplement: Iodized salt

• Registration Number: NCT05166980
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-22
• Study Start: 2022-10-17
• Status Verified: 2024-05
• Primary Completion: 2024-05-02
• Study Completion: 2024-05-02
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1389

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FePP-Q5S	Mutiply-fortified salt	Salt fortified with iron in the form of ferric pyrophosphate (at 1.3 mg of iron per gram of salt) plus ethylenediaminetetraacetic acid (EDTA) as an enhancer of absorption, 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 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the FePP-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day.
Iodized Salt	Iodized salt	Iodized salt containing 30 mg of iodine per gram of salt. Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the iodized salt will deliver an average of 138 mg of iodine to each participating woman per day.
eFF-Q5S	Mutiply-fortified salt	Salt fortified with iron in the form of encapsulated ferrous fumarate (at 1.3 mg of iron per gram of salt), 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 ug per gram of salt) and iodine (at 30 mg of iodine per gram of salt). Mean intake of discretionary salt among women of reproductive age in the study area is 4.6 grams per day. Therefore, the eFF-Q5S will deliver an average of 6.0 mg of iron, 6.4 mg of zinc, 2.8 ug of vitamin B12, 241 ug of folic acid, and 138 mg of iodine to each participating woman per day.

Primary Outcome Measures

Name	Time	Method
Change in serum vitamin B12	Enrollment to 12 months (i.e. end of intervention period)	Change in mean serum vitamin B12 concentration
Change in methylmalonic acid	Enrollment to 12 months (i.e. end of intervention period)	Change in mean concentration of methylmalonic acid
Change in serum folate	Enrollment to 12 months (i.e. end of intervention period)	Change in mean serum folate concentration
Change in urinary iodine	Enrollment to 12 months (i.e. end of intervention period)	Change in mean urinary iodine concentration
Change in plasma zinc	Enrollment to 12 months (i.e. end of intervention period)	Change in mean plasma zinc concentration
Change in soluble transferrin	Enrollment to 12 months (i.e. end of intervention period)	Change in inflammation-adjusted mean soluble transferrin concentration
Change in serum ferritin	Enrollment to 12 months (i.e. end of intervention period)	Change in inflammation-adjusted mean serum ferritin concentration
Change in holo-transcobalamin	Enrollment to 12 months (i.e. end of intervention period)	Change in mean holo-transcobalamin concentration
Change in serum thyroglobulin	Enrollment to 12 months (i.e. end of intervention period)	Change in mean serum thyroglobulin concentration
Change in hemoglobin	Enrollment to 12 months (i.e. end of intervention period)	Change in mean hemoglobin concentration
Change in red blood cell folate	Enrollment to 12 months (i.e. end of intervention period)	Change in mean red blood cell folate concentration

Secondary Outcome Measures

Name	Time	Method
Change in gut microbiota	Enrollment to 12 months (i.e. end of intervention period)	Change in the abundance of potentially beneficial microbiota in the gut
Change in nail zinc	Enrollment to 12 months (i.e. end of intervention period)	Change in mean fingernail zinc concentration

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research, Chandigarh; 🇮🇳 Chandigarh, India