None listed
Conditions
Interventions
Intervention1: Ferrous sulphate: 60 mg of elemental iron
Single dose in the morning on empty stomach
Oral route
For 14 days
Control Intervention1: Ferrous sulphate: 120 mg of elem
Sponsors
University College London in UK
Eligibility
Inclusion criteria
Inclusion criteria: BMI range 18 to 30 kg/m2 Not on any long-term medication, oral contraceptives, or any medications that may affect metabolism of iron in the body. Willing to give informed consent and take oral iron for 2 weeks and be randomized into study intervention group.
Exclusion criteria
Exclusion criteria: Pregnant women Lactating mothers Any current or recent major illness or condition that may interfere with study outcomes (eg, inflammatory illness, diabetes, endocrine disorders, etc) or on medication for any such illness or condition. Infection or febrile illness in the last 2 weeks (but can be recruited 2 weeks later, after resolution of symptoms, if willing to participate). Already on iron supplements or taken them in the past 2 weeks. On dietary supplements containing vitamins (except Ca+, Vit D), minerals, herbal other plant-based preparations (if willing to participate, may do so after stopping these supplements for at least 2 weeks prior to study). Serum CRP levels >6 mg/L. Not willing to give informed consent or take iron supplements as per protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responses seen in iron-related parameters(serum iron, ferritin, total iron-binding capacity, transferrin saturation, hepcidin, soluble transferrin receptor and erythroferrone) and haematolgical parameters (complete blood counts), to the 2 regimes, at the end of 2 weeksTimepoint: On day 15, at the end of 14 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes seen in inflammatory parameters (high-sensitivity C-reactive protein and interleukin 6 in serum) and profile of the gut microbiota in response to the 2 regimes, at the end of 2 weeks Effect of baseline iron status on the responses seen to the 2 regimes, at the end of 2 weeks Timepoint: On day 15, at the end of 14 days of intervention | — |
Countries
India
Contacts
Public ContactMolly Jacob
Christian Medical College, Vellore
Outcome results
None listed