Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid

Summary

The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status. Folate insufficiency is the primary risk factor for neural tube defects (NTDs), which are highly prevalent in Ethiopia. The purposes of Phase 2 of the project, described herein, are to complete a community-based, randomized, dose-response intervention trial of edible salt fortified with just iodine or iodine and one of two levels of folic acid among non-pregnant women of reproductive age (WRA), We will assess the effects of the intervention on women's discretionary salt intakes, markers of folate and iodine status, and incidence of any adverse events.

Conditions

• Folate Deficiency
• Iodine Deficiency
• Anemia Macrocytic
• Anemia Deficiency
• Salt Intake
• Vitamin B 12 Deficiency

Interventions

DIETARY_SUPPLEMENT

Iodized salt

Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.

DIETARY_SUPPLEMENT

Experimental: Iodized salt with lower-dose folic acid fortification

Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.

DIETARY_SUPPLEMENT

Experimental: Iodized salt with higher-dose folic acid fortification

Masked, individually labeled 500-g containers of the study salts will be delivered to the participants' homes bi-weekly by field workers who will collect previously delivered salt containers during the same visit. Participants will be counseled to use the study salt for all food preparation and meal-time seasoning for all members of the household and not to share the salt with others or use it for non-food consumption purposes.

Sponsors & Collaborators

• Ethiopian Public Health Institute

  collaborator OTHER_GOV

• University of California, San Francisco

  collaborator OTHER

• University of Rhode Island

  collaborator OTHER

• Nutrition International

  collaborator OTHER

• University of California, Davis

  lead OTHER

Principal Investigators

• KENNETH H BROWN, MD · UC Davis

• Masresha Tessema, PhD · Ethiopian Public Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-25

Primary Completion

2024-12-16

Completion

2024-12-16

Countries

• Ethiopia

Study Locations