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Quadruple Fortified Salt Trial in India

NCT03853304 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-04-01

No results posted yet for this study

Summary

Women of reproductive age are at an increased risk of anemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of neural tube defects and other pregnancy complications. Vitamin B12 deficiency is a risk factor for neural tube defects and may modify folate biomarkers that predict neural tube defect risk at the population level. There is an interest in mandatory fortification with vitamin B12 and folic acid for anemia and birth defect prevention. However, there are limited population-representative data needed to inform policy and guidelines. This randomized trial will be conducted to evaluate the efficacy of quadruple-fortified salt (QFS; iron, iodine, folic acid, vitamin B12) in 1,000 women and their households in Southern India.

Conditions

  • Anemia
  • Folate Deficiency
  • Vitamin B 12 Deficiency

Interventions

OTHER

+ Folic acid

Salt fortified with folic acid

OTHER

+ Vitamin B12

Salt fortified with vitamin B12

OTHER

DFS

Salt fortified with iron and iodine

Sponsors & Collaborators

Principal Investigators

  • Julia L Finkelstein, MPH SM ScD · Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853304 on ClinicalTrials.gov