Evidence map›Paper›PMID 39477275›Full record

ArticleBMJ open2024

Protocol for a community-based, household-randomised, dose-response trial to assess the acceptability, nutritional effects and safety of double-fortified salt containing iodine and folic acid compared with iodised salt among non-pregnant Ethiopian women of reproductive age (DFS-IoFA).

Kenneth H Brown, Masresha Tessema, Christine M McDonald, Isaac Agbemafle, Meseret Woldeyohannes, Mengistu Fereja, Debritu Nane, Charles D Arnold, Feyissa Challa Waka, Biniyam Tesfaye and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06223854 (Evaluation of the Acceptability and Nutritional Effects of Double-fortified Salt Containing Folic Acid and Iodine Among Ethiopian Women of Reproductive Age - a Household-randomized, Controlled, Community-based Trial), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06223854 nacompletednot on this map

Evaluation of the Acceptability and Nutritional Effects of Double-fortified Salt Containing Folic Acid and Iodine Among Ethiopian Women of Reproductive Age - a Household-randomized, Controlled, Community-based Trial

TypeinterventionalSponsorUniversity of California, DavisRan2024 to 2024Enrolled360ConditionsFolate Deficiency, Iodine Deficiency, Anemia Macrocytic, Anemia DeficiencyArmsIodized salt, Experimental: Iodized salt with lower-dose folic acid fortification, Experimental: Iodized salt with higher-dose folic acid fortification
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kenneth H BrownDepartment of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA khbrown@ucdavis.edu.ORCID 0000-0001-6498-3120
Masresha TessemaFood Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.ORCID 0000-0002-7155-4815
Christine M McDonaldDepartment of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA.ORCID 0000-0003-1231-9003
Isaac AgbemafleDepartment of Nutrition, University of Rhode Island, Kingston, Rhode Island, USA.ORCID 0000-0003-4320-7303
Meseret WoldeyohannesFood Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.ORCID 0000-0001-8538-3466
Mengistu FerejaFood Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.ORCID 0009-0008-1539-2015
Debritu NaneDepartment of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA.
Charles D ArnoldDepartment of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA.ORCID 0000-0001-6510-3172
Feyissa Challa WakaFood Science and Nutrition Research Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.ORCID 0000-0002-2624-6661
Biniyam TesfayeDepartment of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, California, USA.
Mandana ArabiGlobal Technical Services, Nutrition International, Ottawa, Ontario, Canada.
Homero MartinezGlobal Technical Services, Nutrition International, Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe prevalence of neural tube defects (NTDs) is higher in Ethiopia than most other countries, and ~84% of Ethiopian women of reproductive age (WRA) have folate insufficiency, a major risk factor for NTDs. Salt fortification with folic acid is a potential strategy to improve women's folate status, but data are needed on the acceptability, nutritional impact and safety of folic acid fortification of iodised salt. METHODS AND ANALYSIS: The study is designed as a community-based, household-randomised, dose-response trial. A total of 360 non-pregnant WRA 18-49 years of age will be randomly assigned to one of three intervention arms: (1) iodised salt fortified with 30 ppm folic acid to provide ~200 µg folic acid/day; (2) iodised salt fortified with 90 ppm folic acid to provide ~600 µg folic acid/day; or (3) iodised salt (comparator). The preweighed salts will be delivered to participants' homes biweekly for 26 weeks; unused salt will be collected and weighed. Fasting, venous blood samples will be collected at baseline, end line and a randomly assigned intermediate time point for assessment of folate, iodine, vitamin B ETHICS AND DISSEMINATION: The study has been approved by the Ethiopian Public Health Institute's Institutional Review Board, and the protocol has been registered with ClinicalTrials.gov (registration number NCT06223854). Study results will be published in open access scientific journals and disseminated nationally in Ethiopia. TRIAL REGISTRATION NUMBER: NCT06223854.

Indexed as

Folic AcidIodineSodium Chloride, DietaryAdolescentAdultEthiopiaFemaleFolic Acid DeficiencyFood, FortifiedHumansMiddle AgedNeural Tube DefectsNutritional StatusRandomized Controlled Trials as TopicYoung AdultFolic AcidIodineiodized saltSodium Chloride, DietaryEpidemiologyNutrition & DieteticsPreventive MedicinePublic Health

Identifiers

PMID39477275
PMCPMC11529693

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.