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LOBSTERNCT07394972

Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved at least 6 months later.

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from May 2026 to Dec 2026 Show 6 more changesShow less
    • Eligibility criteria shortened, about 27 words
    • Enrollment closed, study ongoing
    • Study completion pushed from May 2026 to Feb 2027
    • Start date changed from estimate of Feb 17, 2026 to Mar 2, 2026
    • Secondary endpoints: details revised at 16 of 16 entries
    • Site details revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: May 5, 2026 to May 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Fractional iron absorption (%)
Timeframe: Day 22

Secondary (5)

Hemoglobin (g/dL)
Serum Ferritin (µg/L)
soluble Transferrin Receptor (mg/L)
C-reactive protein (mg/L)
Alpha-1-acid Glycoprotein (g/L)

Arms and interventions

Ferrous sulfate + inhibitory mealActive comparator

4 mg of iron (58Fe) as ferrous sulfate + inhibitory meal

Ferrous sulfate + native LF + inhibitory mealActive comparator

4 mg iron (58Fe) as ferrous sulfate + native LF + inhibitory meal

Ferrous sulfate + encapsulated LF (sodium caseinate) + inhibitory mealExperimental

4 mg iron (57Fe) as ferrous sulfate + sodium caseinate-LF + inhibitory meal

Encapsulated LF-Fe (Sodium caseinate) + inhibitory mealExperimental

4 mg of iron (54Fe) encapsulated with LF in sodium caseinate + inhibitory meal

Ferrous sulfate + encapsulated LF (low methoxy pectin) + inhibitory mealExperimental

4 mg of iron (54Fe) as ferrous sulfate + low methoxy pectin-LF + inhibitory meal

Encapsulated LF-Fe (low methoxy pectin) + inhibitory mealExperimental

4 mg of iron (57Fe) encapsulated with LF in low methoxy pectin + inhibitory meal

Encapsulated LF-Fe (sodium caseinate) + waterExperimental

100 mg of iron encapsulated with LF in sodium caseinate + water

Encapsulated LF-Fe (low methoxy pectin) + waterExperimental

100 mg of iron encapsulated with LF in low methoxy pectin + water

Ferrous sulfate + waterActive comparator

100 mg of iron as ferrous sulfate + water

Other: FeSO4 + meal-matrix, FeSO4 + native LF + meal-matrix, FeSO4 + NaCas-LF + meal-matrix, NaCas-LF-Fe + meal-matrix, FeSO4 + LMP-LF + meal-matrix, LMP-LF-Fe + meal-matrix, NaCas-LF-Fe + water, LMP-LF-Fe + water, FeSO4 + water

Sites

1 site in 1 country

  • ETH Zurich, Laboratory of Clinical BiopharmacyZurich, Switzerland