| CTRI Number |
CTRI/2026/03/105930 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Micronutrient Fortified Salt Intervention] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Salt Fortification for Nutritional Enhancement and Hematologic Advancement (SNEHA) Trial |
|
Scientific Title of Study
|
A Randomized Controlled Study to Evaluate the Efficacy of Quadruple Fortified Salt (Iron, Iodine, Folic Acid, and Vitamin B12) in Improving Anaemia and Micronutrient Status among Early Adolescent, Women of Reproductive age, and Women aged 50 and above in Southern India: Salt Fortification for Nutritional Enhancement and Hematologic Advancement (SNEHA) Trial |
| Trial Acronym |
SNEHA Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIN/IEC/2026/1/NR/002 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Samarasimha Reddy |
| Designation |
Scientist E |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
Dr. N. Samarasimha Reddy, Scientist-E, Room No. 36, Clinical Epidemiology Division, Epidemiology Department, Beside Tarnaka Metro station, ICMR-National Institute of Nutrition, Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9963876468 |
| Fax |
|
| Email |
drsamarareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Samarasimha Reddy |
| Designation |
Scientist E |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
Dr. N. Samarasimha Reddy, Scientist-E, Room No. 36, Clinical Epidemiology Division, Epidemiology Department, Beside Tarnaka Metro station, ICMR-National Institute of Nutrition, Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9963876468 |
| Fax |
|
| Email |
drsamarareddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Samarasimha Reddy |
| Designation |
Scientist E |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
Dr. N. Samarasimha Reddy, Scientist-E, Room No. 36, Clinical Epidemiology Division, Epidemiology Department, Beside Tarnaka Metro station, ICMR-National Institute of Nutrition, Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9963876468 |
| Fax |
|
| Email |
drsamarareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division of Nutritional Sciences, Cornell University, ITHACA, New York, United states of America- 14853 |
|
|
Primary Sponsor
|
| Name |
Cornell University |
| Address |
Cornell University
Martin Y. Tang Welcome Center
616 Thurston Ave.
Ithaca, NY 14853 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Samarasimha Reddy N |
Model Rural Health Research Unit (MRHRU) |
Population Health Research Centre
(MRHRU / PHRC), Room No. 1,
Near clock Tower,
Chandragiri village, Chandragiri Mandal, Tirupati District, Andhra Pradesh, India.
Pincode: 517 101
Chittoor
ANDHRA PRADESH |
9963876468
drsamarareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR-National Institute of Nutrition Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nutritional Anaemia and Micronutrient Deficiency (Iron, Folate and Vitamin B12 Deficiency) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Double Fortified Salt (Iodine + Iron) |
Salt fortified with iodine (potassium iodate 30 ppm) and microencapsulated iron (ferrous fumarate 1100 ppm elemental iron). Provided in 500 g color-coded packets monthly for 12 months for household consumption. |
| Intervention |
Double Fortified Salt plus Folic Acid |
Salt fortified with iodine (potassium iodate 30 ppm), microencapsulated iron (ferrous fumarate 1100 ppm elemental iron), and folic acid (30 µg/g). Provided in 500 g color-coded packets monthly for 12 months for household consumption. |
| Intervention |
Double Fortified Salt plus Vitamin B12 |
Salt fortified with iodine (potassium iodate 30 ppm), microencapsulated iron (ferrous fumarate 1100 ppm elemental iron), and vitamin B12 (cyanocobalamin 0.3 µg/g). Provided in 500 g color-coded packets monthly for 12 months for household consumption. |
| Intervention |
Quadruple Fortified Salt (Double Fortified Salt plus Folic Acid and Vitamin B12) |
Salt fortified with iodine (potassium iodate 30 ppm), microencapsulated iron (ferrous fumarate 1100 ppm elemental iron), folic acid (pteroylmonoglutamic acid 30 µg/g), and vitamin B12 (cyanocobalamin 0.3 µg/g). Salt will be provided in 500 g color-coded packets monthly for 12 months for household consumption. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Early adolescent girls (10-14 years), women of reproductive age group (15-49 years) and women aged 50 years and above
Healthy (defined further below under exclusion criteria)
Not pregnant or lactating
Plan to reside within the study area for at least two years.
|
|
| ExclusionCriteria |
| Details |
Severe anaemia (Haemoglobin less than 8.0 g/dL)
Reported diagnosis of HIV, malaria infection, or active tuberculosis disease
Malabsorption disorders (e.g., inflammatory bowel disease; i.e., medical conditions that may affect vitamin B12 absorption or metabolism)
Stage 2 hypertension (i.e., systolic blood pressure (SBP) more than equal to 140 mm Hg or diastolic blood pressure (DBP) more than equal to 90 mm Hg)
Glycated haemoglobin (HbA1c) more than equal to 6.5%
Other serious pre-existing medical conditions (i.e., defined as the need for regular medication use), including diabetes, chronic kidney disease, cardiovascular disease, and thyroid disease
Active infections or acute illnesses (e.g., fever, malaria, dengue, blood in stool)
Previous pregnancy affected by a neural tube defect (i.e., who have had a foetus diagnosed as affected by a neural tube defect or have given birth to a baby with a neural tube defect) (will be referred to OB/GYN for standard of care, including folic acid supplementation, and excluded)
Planning to become pregnant (or planning to have a child) in the next 12 months (will be referred to OB/GYN for standard of care, including folic acid supplementation, and be excluded)
Taking daily (more than or equal to 4 times in the past week) micronutrient supplements (i.e., tablets, capsules, dispersible tablets)
Received an intramuscular or intravenous intervention containing medications or micronutrients (e.g., iron, vitamin B12, folic acid) in the past 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in haemoglobin concentration (g/dL), red blood cell folate concentration (nmol/L), and serum total vitamin B12 concentration (pmol/L) among early adolescent girls (10-14 years), Women of Reproductive age group (15-49 years) and women aged 50 years and above in Southern India. |
Baseline and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of anaemia |
Baseline and 12 months |
| Prevalence of folate deficiency and folate insufficiency among women of reproductive age (15-49 years). |
Baseline and 12 months |
| Prevalence of vitamin B12 among women of reproductive age (15-49 years). |
Baseline and 12 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized double blind two by two factorial controlled trial designed to evaluate the efficacy of micronutrient fortified salt on nutritional status among females in Southern India. The trial will assess the effects of salt fortified with iodine and iron with or without folic acid and vitamin B12 on haemoglobin concentration red blood cell folate concentration and serum total vitamin B12 concentration.
A total of 1000 eligible female participants will be enrolled from rural households in Andhra Pradesh India. The study population includes early adolescent girls aged 10 to 14 years women of reproductive age aged 15 to 49 years and women aged 50 years and above. One eligible woman aged 15 to 49 years per household will be randomly selected as the index participant for primary intention to treat analyses. Participants and investigators will remain blinded to treatment allocation throughout the study period. Fortified salt will be distributed monthly for household consumption for a duration of 12 months.
The primary objective is to determine whether consumption of fortified salt improves haemoglobin red blood cell folate and vitamin B12 concentrations at 12 months compared with baseline among women of reproductive age. Secondary outcomes include the prevalence of anaemia folate deficiency and vitamin B12 deficiency. The study hypothesis is that fortified salt containing folic acid and vitamin B12 in addition to iron and iodine will significantly improve micronutrient status among females across the life course in the study population. |