Nutrient Deficiency
Conditions
Keywords
Micronutrient deficiencies
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.
Interventions
DIETARY_SUPPLEMENTMutiply-fortified salt
Salt fortified with iron, zinc, vitamin B12, folic acid, and iodine
DIETARY_SUPPLEMENTIodized salt
Salt fortified with iodine
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
University of California, Davis
University of Colorado, Denver
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study salts will be packaged in color-coded, polyethylene bags.
Intervention model description
3-armed, double-blind, community-based efficacy trial
Eligibility
Sex/Gender
ALL
Age
12 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
for women of reproductive age: 1. 18-49 years of age; 2. Not currently pregnant (self-reported); 3. Not severely anemia (defined as a hemoglobin concentration \< 8 g/dL); 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
for women of reproductive age: 1. Age \<18 or \> 49 years of age; 2. Pregnant at the time of enrollment (self report) or planning to become pregnant within the next year; 3. Severely anemic (i.e. hemoglobin concentration \< 8 g/dL); 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 the primary source of the household's discretionary salt. Inclusion criteria for preschool children: 1. Child 12-59 months of age at the time of enrollment; 2. Child's mother or primary female caregiver has been enrolled into the parent trial; 3. Not severely anemic (defined as a hemoglobin concentration \< 7 g/dL); 4. Child'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 child's eating practices; 6. Child's mother or primary female caregiver is willing to use refined salt provided by the study as the primary source of the household's discretionary salt for the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum thyroglobulin | Enrollment to 12 months (i.e. end of intervention period) | Change in mean serum thyroglobulin concentration |
| 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 serum ferritin | Enrollment to 12 months (i.e. end of intervention period) | Change in inflammation-adjusted mean serum ferritin concentration |
| Change in hemoglobin | Enrollment to 12 months (i.e. end of intervention period) | Change in mean hemoglobin 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 red blood cell folate | Enrollment to 12 months (i.e. end of intervention period) | Change in mean red blood cell folate concentration |
| Change in plasma zinc | Enrollment to 12 months (i.e. end of intervention period) | Change in mean plasma zinc concentration |
| Change in serum vitamin B12 | Enrollment to 12 months (i.e. end of intervention period) | Change in mean serum vitamin B12 concentration |
| Change in holo-transcobalamin | Enrollment to 12 months (i.e. end of intervention period) | Change in mean holo-transcobalamin concentration |
| Change in methylmalonic acid | Enrollment to 12 months (i.e. end of intervention period) | Change in mean concentration of methylmalonic acid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
India
Outcome results
None listed