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A trial to test whether micronutrient status in a rural Ethiopian population can be improved through the consumption of teff flour biofortified using selenium and zinc fertilizers

Alleviating Hidden Hunger with Agronomy: a randomised, controlled trial in rural Ethiopia to test the efficacy of improving selenium and zinc status through consumption of teff flour biofortified using selenium and zinc fertilizers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10026749
Enrollment
140
Registered
2021-01-04
Start date
2021-03-15
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selenium and zinc deficiency Nutritional, Metabolic, Endocrine Selenium and zinc deficiency

Interventions

Using a computer-based randomisation programme, participant households will be randomly allocated in a 1:1 ratio to either the intervention or control arm. The intervention arm will receive teff flour

Sponsors

London School of Hygiene & Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Household level: 1. Household members include at least one non-pregnant woman of reproductive age (20-45 years) and at least one school-aged child (5-10 years) 2. Household typically prepares and consumes meals at home 3. Household head agrees that the household will receive and all members consume teff flour for the 60 day flour distribution period 4. No confirmed, suspected, or probable cases of COVID-19 in the household in the past 14 days Individual level: 1. Individual is not pregnant (self-reported) and is apparently healthy 2. Planning to be in residence in the household during the intervention period 3. Participant woman of reproductive age is willing and able to provide consent, and the caretaker of the participant school-aged child is willing and able to provide assent

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
1. Blood plasma selenium concentration (in µg/l) measured using Inductively Coupled Plasma Mass Spectrometry (ICPMS) with plasma samples collected at endline

Secondary

MeasureTime frame
Current secondary outcome measures: 1. The Relative Risk of selenium deficiency, defined as <70µg/l at endline 2. Plasma zinc concentration (mg/l) measured by ICPMS at endline 3. Plasma copper to zinc molar ratio measured using plasma samples at endline _____ Previous secondary outcome measures: 1. The Relative Risk of selenium deficiency, defined using established thresholds for the optimal activity of Glutathione peroxidase 3 (GPx-3) (<84.9?µg l-1) and iodothyronine deiodinase (IDI) (<64.8?µg l-1) at endline 2. Plasma zinc concentration (mg l-1) before and after correction for inflammation status measured using ICPMS at endline 3. Plasma copper to zinc molar ratio measured using plasma samples at endline 4. Plasma Linoleic Acid to Dihomo-?-Linolenic Acid ratio (LA:DGLA) measured using plasma samples at endline 5. Plasma Arachidonic acid to Dihomo-?-Linolenic Acid ratio (AA:DGLA) measured using plasma samples at endline 6. Concentration of haemoglobin in whole venous blood (g dl-1) measured in the field using a portable HemoCue Hb301+ (HemoCue AB, Ängelholm, Sweden) at endline

Countries

Ethiopia

Contacts

Public ContactEdward Joy
edward.joy@lshtm.ac.uk+44 2079272214

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026