CompletedNot Applicable

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

Ethiopia360 participantsStarted 2024-04-25

Plain-language 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.

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-pregnant * Using long-acting contraceptive * Intending to remain in study community for at least six months * Willing to use study salt for all household food preparation and seasoning * Signed, informed consent Exclusion Criteria: * Pregnant * Not using long-acting contraceptive * Acute or chronic disease that affects dietary intake or folate metabolism * Hypertension * Medications that potentially interfere with folate metabolism * Folic acid-containing vitamin supplements * Macrocytic anemia or moderate/severe non-macrocytic anemia. * Mid-upper arm circumference \<23 cm and breast feeding an infant \<6 months of age

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Red blood cell folate

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum folate

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum homocysteine

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum thyroglobulin

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

24-hour urinary iodine excretion

Timeframe: Before and during the intervention

Serious adverse events

Timeframe: Throughout the course of the intervention, total of 26 weeks

Trial details

NCT IDNCT06223854

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-16

View on ClinicalTrials.gov More Folate Deficiency trials

Plain-language summary

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Red blood cell folate

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum folate

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum homocysteine

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

Serum thyroglobulin

Timeframe: Baseline (pre-intervention), intermediate time point (between 4-20 weeks), and end line (24-26 weeks)

24-hour urinary iodine excretion

Timeframe: Before and during the intervention

Serious adverse events

Timeframe: Throughout the course of the intervention, total of 26 weeks