Deficiency of selenium Nutritional, Metabolic, Endocrine
Conditions
Interventions
Current interventions as of 21/06/2019:
The study area was defined by selecting two neighbouring Enumeration Areas with sufficient population to meet the target sample size, based on e
Sponsors
London School of Hygiene & Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/06/2019: Household level: 1. Participating households should have at least one non-pregnant woman of reproductive age (WRA; 20-45 years) and at least one school-aged child (SAC; 5-10 years) in residence during July-October 2. Household typically prepares and consumes meals at home 3. Household head provides permission to receive and consume assigned flour in place of their own flour for 12-week flour distribution period Individual level: 1. One WRA and one SAC will be randomly selected to participate from each eligible household. Pregnancy status will be self-reported 2. Participant is planning to be in residence during July-October 3. Participant WRA is willing and able to provide consent, and caretaker of participant SAC is willing and able to provide assent Previous inclusion criteria: 1. Participating households should have at least one non-pregnant woman of reproductive age (WRA; 20-45 years) and at least one school-aged child (SAC; 5-10 years). Pregnancy status will be self-reported. One WRA and one SAC will be randomly selected to participate from each eligible household 2. Household typically prepares and consumes meals at home 3. Household are willing and able to receive and consume assigned flour in place of their own flour for 12-week flour distribution period 4. Individual participants are willing and able to give informed consent (for WRA) or assent (for SAC)
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 21/06/2019: Serum selenium concentration Serum selenium concentration will be determined by Inductively-Coupled Plasma Mass Spectrometry (ICP-MS). The unit of measure is µg Se/L of serum. Serum Se concentrations will be compared against established thresholds for deficiency measured at baseline and 12-weeks. Previous primary outcome measure: 1. Zinc arm: DNA fragmentation analysis DNA fragmentation will be quantified using the Comet Assay method and Comet Assay IV Lite software (Perceptive Instruments, London, UK) will be used to measure tail moments. The unit of measure is mean (±SEM) comet tail moment, defined as the product of the tail length and the fraction of total DNA in the tail (Tail moment=tail length x % of DNA in the tail) measured at baseline and 12-weeks. 2. Selenium arm: Serum selenium concentration Serum selenium concentration will be determined by Inductively-Coupled Plasma Mass Spectrometry (ICP-MS). The unit of measure is µg Se/L of serum. Serum Se concentrations will be compared against established thresholds for deficiency measured at baseline and 12-weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/06/2019: 1. Haematology Haemoglobin concentrations will be measured using HemoCue and compared against standard thresholds to indicate anaemia status. Inflammatory markers (a1-acid glycoprotein and C-reactive protein) will be measured using a sandwich ELISA. Measured at baseline and 12-weeks. 2. Morbidity Diarrhoea incidence, severity and duration, incidence of vomiting and incidence of fever will be recorded. Prevalence of pneumonia will be measured among school-aged children, i.e. number of days of coughing and fast or difficult breathing (due to a problem in the chest) in the two weeks prior to the baseline and end-line surveys. 3. Dietary selenium supplies Dietary data will be collected among participating women of reproductive age using 4-pass interactive 24-hour recall at baseline and end-line surveys. Dietary data will be collected across all days of the week (population level) to account for any day of the week effect. Dietary data will be combined with relevant food composition data (including specific data for intervention maize flour) to determine the intakes of energy and nutrients (including selenium). The percentage of women at risk of inadequate intakes of selenium will be estimated using the Estimated Average Requirement cut-point method after adjustment for intra-subject variability. The percentage of energy from food groups, sub-groups and specific foods will be estimated to examine changes in diet patterns. Previous secondary outcome measures: 1. Serum zinc concentration Serum zinc concentration will be determined by Inductively-Coupled Plasma Mass Spectrometry (ICP-MS). The unit of measure is mg Zn/L of serum. Serum zinc concentrations will be compared against established thresholds for deficiency, adjusted for inflammation. Measured at baseline and 12-weeks. | — |
Countries
Malawi
Outcome results
None listed