Authors
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South Australian Health and Medical Research Institute (SAHMRI) -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2019
INTERVENTION: This study is a three‐arm, parallel‐group, randomised controlled trial with a 15‐week intervention period followed by a 4‐week washout period. Interventions include: Arm 1: 60 mg of elemental iron as ferrous fumarate and 2.8 mg of folic acid once weekly. This dose will be administered orally in tablet form once weekly for 15 weeks. Adherence will be assessed by counting remaining tablets at the end of the intervention period by study staff. Arm 2: 60 mg of elemental iron as ferrous fumarate and 0.4 mg of folic acid. This dose will be administered orally in tablet form once weekly for 15 weeks. Adherence will be assessed by counting remaining tablets at the end of the intervention period by study staff. CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Public Health ‐ Other public health Red blood cell folate; ; Red blood cell folate PRIMARY OUTCOME: Red blood cell folate (nmol/L); Measurement: Microtiter technique with chloramphenicol‐resistant Lactobacillus casei as the test microorganism. This will be calculated from whole blood folate by subtracting plasma folate and correcting for haematocrit. [Baseline (0 weeks), 15 weeks, and 19 weeks] SECONDARY OUTCOME: a‐1 acid glycoprotein (AGP, g/L) ; Measurement: Single sandwich‐enzyme linked immunosorbent assay [Baseline (0 weeks) and 15 weeks] C‐reactive protein (CRP, mg/L) ; Measurement: Single sandwich‐enzyme linked immunosorbent assay [Baseline (0 weeks) and 15 weeks] Anaemia prevalence (haemoglobin < 120 g/L) ; Measurement: complete blood count[Baseline (0 weeks), 15 weeks, and 19 weeks] Haemoglobin (g/L) ; Measurement: complete blood count [Baseline (0 weeks), 15 weeks, and 19 weeks] Plasma ferritin (µg/L) ; Measurement: Single sandwich‐enzyme linked immunosorbent assay [Baseline (0 weeks) and 15 weeks] Plasma folate (µg/L) ; Measurement: Microtiter technique with chloramphenicol‐resistant Lactobacillus casei as the test microorganism.[Baseline (0 weeks), 15 weeks, and 19 weeks] Plasma pyridoxal‐5’‐phosphate (nmol/L) ; Measurement: High Performance Liquid Chromatography [Baseline (0 weeks), 15 weeks, and 19 weeks] Plasma vitamin B12 (pmol/L) ; Measurement: Elecsys® 2010 (Roche Diagnostics, Switzerland) automated electrochemiluminescence immunoassay[Baseline (0 weeks), 15 weeks, and 19 weeks] Retinol binding protein (RBP, µmol/L)] ; Measurement: Single sandwich‐enzyme linked immunosorbent assay [Baseline (0 weeks) and 15 weeks] Soluble transferrin receptor (sTfR, mg/L) ; Measurement: Single sandwich‐enzyme linked immunosorbent assay [Baseline (0 weeks) and 15 weeks] Whole blood folate ; Measurement: Microtiter technique with chloramphenicol‐resistant Lactobacillus casei as the test microorganism ; ; [Baseline (0 weeks), 15 weeks, and 19 weeks] INCLUSION CRITERIA: Non‐pregnant (self‐reported), not planning on becoming pregnant, not currently taking micronutrient supplements or participating in another nutritional intervention, apparently healthy, not taking any medication, and not planning to leave the community for the timeline of the study.
Epistemonikos ID: d3f32a727ace412231e49d24f0c39a0ea6441adc
First added on: Aug 24, 2024