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Register:	ISRCTN
Last refreshed on:	3 October 2023
Main ID:	ISRCTN83678069
Date of registration:	02/08/2017
Prospective Registration:	Yes
Primary sponsor:	University of Central Lancashire
Public title:	Biofortification with zinc in flour for eliminating deficiency
Scientific title:	Examining the effectiveness and acceptability of the use of biofortified crops in alleviating micronutrient deficiencies in Pakistan: a randomised cross over trial
Date of first enrolment:	01/09/2017
Target sample size:	50
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN83678069
Study type:	Interventional
Study design:	Double-blind randomised cross over trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Pakistan

Contacts

Name:	Nicola Lowe
Address:	Faculty of Health and Wellbeing 230 Darwin Building University of Central Lancashire PR1 2HE Preston United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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: Pregnant or lactating women

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

ZInc deficiency
Nutritional, Metabolic, Endocrine
Dietary zinc deficiency

Intervention(s)

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 community in North West Pakistan.

Randomisation procedure of study area
Stratified cluster sampling with block design. The field study district has 10 hamlets (clusters). Out of these 10 hamlets (clusters), 5 were randomly selected using research Randomiser software. These included:

Cluster 1. Number of Households = 1600 (approx. 500 in each part)
Cluster 2. No. of households = 100
Cluster 3. No. of households = 200
Cluster 4. No. of households = 125
Cluster 5. No. of households = 250

To select an equal number of households from each cluster, each household in each cluster was numbered from 1 to 500, 1 – 100, 1-200, 1-125, 1-250, respectively. The following households were randomly selected from each cluster:

Cluster Randomly Selected Household
1 295, 160, 301, 351, 33, 45, 248, 224, 17, 409
2 19, 67, 46, 58, 45, 66, 83, 42, 34, 57
3 111, 125, 114, 123, 37, 139, 63, 126, 132, 98
4 121, 47, 96, 63, 54, 85, 114, 20, 104, 49
5 247, 180, 248, 182, 14, 167, 166, 36, 201, 157

Selection of each household into the intervention or control arm will be done using a block design.

The high zinc grain will be compared with standard grain, both of which will be provided to 40 families to consume for eight weeks, with group A consuming the high zinc grain and group B consuming the control grain. The families will switch over after eight weeks. To monitor the impact of consuming the flour on zinc status established methods will be used (plasma and hair zinc concentration), and new indicators of zinc status will also be evaluated that have pote

Primary Outcome(s)

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 Outcome(s)

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 middle and end of phase 1 (weeks 6 and 10), and the middle and end of crossover phase 2 (weeks 14 and 18).

6. Incidence of diarrhoea: Mothers will be asked to keep a continuous record the incidence and duration of diarrhoeal episodes amongst the children of the household throughout the study (weeks 1 to 18)

7. Dietary nutrient intake will be assessed by 24-hour recall and food frequency, interview administered, questionnaire at 3 time points during the study: During the equilibration period (weeks 1-2), at the mid point of phase 1 (week 6) and the mid point of phase 2 (week 10). Data collection will be by interview conducted by the Nutritionist employed on the study.

8. Stool samples will be collected at 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). These samples will be stored for future microbiome analysis, when further funding is secured.

Secondary ID(s)

Source(s) of Monetary Support

Biotechnology and Biological Sciences Research Council

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; University of Central Lancashire, STEMH Ethics Committee, 11/09/2007, ref: STEMH 697 FR

Results

Results available:	Yes
Date Posted:
Date Completed:	30/04/2019
URL:

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