ZInc deficiency Nutritional, Metabolic, Endocrine Dietary zinc deficiency
Conditions
Interventions
A double-blind trial will be conducted to examine whether or not consuming the flour made from the high zinc grain has a beneficial impact on the zinc status of zinc deficient women living in a rural
Sponsors
University of Central Lancashire
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Members of the target community, located on the brick kilns in Peshawar, North West Pakistan 2. Female, aged 16 to 49 years
Exclusion criteria
Exclusion criteria: Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Samples are taken for analysis at the end of the equilibration period (week 2), the middle and end of phase 1 (weeks 6 and 10), and the middle and end of crossover phase 2 (weeks 14 and 18): 1. Plasma zinc concentration, measured by inductively coupled plasma mass spectrometry (ICP-MS) 2. DNA fragmentation, measured using the comet assay 3. Hair and nail zinc concentration, measured by laser induced breakdown spectroscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Samples for the following assays are taken for analysis at the end of the equilibration period (week 2), the middle and end of phase 1 (weeks 6 and 10), and the middle and end of crossover phase 2 (weeks 14 and 18): 1. Biochemical markers of nutrient status: haematocrit, haemoglobin, MCV, UIBC, transferrin saturation estimated using clinical haematology methods. Blood samples analysed for micronutrient status including serum transferrin receptor and ferritin (sandwich ELISA), serum Zn and iron (ICPMS), vitamin A (retinol binding protein, commercial kit). 2. Vitamin A status will be assessed by the ability of the eye to adapt in darkness using a portable field dark adaptometer at three time points (during equilibration (weeks 1-2), end of phase 1 (weeks 6-10), and end of phase 2 (weeks 14-18)). Dark adaptometry also called ‘night vision test’ measures the recovery of visual sensitivity as you go from lit to a dark environment. The process involves briefly exposing the eyes to very bright light and then place a pair of goggles over the eyes for a period of 10 minutes, enabling the eyes to adapt to the dark. Over the following 2 minutes, an LED light in the goggle flashes series of one-second light stimuli into one of the eye, while an infra-red camera records the subject’s pupillary response in the other eye. 3. Protein and lipid content of tears will be analysed using proteomics and metabolomics. Tear samples will be collected at three time points (during equilibration (weeks 1-2), end of phase 1 (weeks 6-10), and end of phase 2 (weeks 14-18)) and will be cryopreserved using Schirmer Tear Test (Haag-Streit UK, product number 4701001) strips. 4. Inflammatory markers (a1-acid glycoprotein (AGP) and C- reactive protein (CRP)) will be analysed using commercial kits 5. Anthropometry: Women will be measured at baseline (during week 2) and end point (Week 18). Children in the household will be measured monthly, end of the equilibration period (week 2), the midd | — |
Countries
Pakistan
Outcome results
None listed