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Biofortification with zinc and iron for eliminating deficiency in Pakistan

A randomised controlled trial to investigate the effect of biofortification on zinc and iron status in adolescent girls in a low resource community in Pakistan

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17107812
Enrollment
500
Registered
2019-08-14
Start date
2019-09-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Zinc and iron deficiencies Nutritional, Metabolic, Endocrine

Interventions

Phase 1 (November 2019 to April 2020): Families will continue to consume their usual, locally purchased flour. The cost of the flour will be reimbursed in the form of coupons to use at the local marke

Sponsors

University of Central Lancashire
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Households will be invited to participate in this study if they include an unmarried adolescent girl (aged 10-16 years) who is not pregnant or lactating AND a child (aged 1–5 years)

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Plasma zinc concentration measured by inductively coupled plasma mass spectrometry (ICP-MS) at start of phase 1 (T1), middle of phase 1 (T2), end of phase 1 (T3), middle of phase 2 (T4), end of phase 2 (T5)

Secondary

MeasureTime frame
Measured at the start of phase 1 (T1), middle of phase 1 (T2), end of phase 1 (T3), middle of phase 2 (T4), end of phase 2 (T5): 1. Biochemical indicators of zinc and iron status (adolescents only): 1.1. Serum iron concentration measured by ICP-MS 1.2. Serum transferrin receptor protein and serum ferritin measured by sandwich ELISA 1.3. Haemoglobin, haematocrit and complete blood count (CBC) estimated using clinical haematology methods 1.4. Inflammatory markers (CRP and AGP) measured by sandwich ELISA 1.5. DNA damage measured by comet assay and histone H2A phosphorylation 1.6. Hair zinc concentration measured by mass spectroscopy 1.7. Natural zinc stable isotope composition measured by ICP-MS 2. Anthropometric measures (adolescents and children): 2.1. Height/length measured using stadiometer or infant measuring board 2.2. Weight measured using digital weighing scale 2.3. Mid upper arm circumference (MUAC), waist circumference, hip circumference and head circumference measured using standard techniques and measuring tape 3. Dietary intake of energy and nutrients (adolescents only) assessed by 24-hour recall method 4. Diarrhoeal episodes: frequency and duration (children only) assessed by interview with mother 5. Upper respiratory tract infections (adolescents and children) assessed by clinical staff

Countries

Pakistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026