Is it better to give women iron tablets on alternate days, instead of daily, to ensure that they have enough iron in their body?
- Registration Number
- CTRI/2020/03/024144
- Lead Sponsor
- niversity College London in UK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 <br/ ><br>Effect of baseline iron status on the responses seen to the 2 regimes, at the end of 2 weeks <br/ ><br>Timepoint: On day 15, at the end of 14 days of intervention