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NCT Number: NCT05973552

Iron Absorption and Requirements in Pregnancy and Lactation

Iron requirements increase significantly during pregnancy. Current recommendations for iron intake in pregnant and lactating women (PLW) are mainly based on factorial estimates and extrapolated from non-PLW. High-quality quantitative data on iron requirements in PLW are lacking, particularly in Sub- Saharan Africa where anaemia and infections are common.

The primary objective of this study is to use the stable iron isotope technique to determine iron requirements and assess iron absorption and losses in PLW living in Kenya.

In this prospective observational study, we will enrol pregnant women in the first trimester (n = 250) from a previous study cohort (n=1000) who participated in an iron absorption study at least 12 months ago and received the stable iron (Fe) isotope 57Fe. This 57Fe has now distributed and equilibrated throughout the women's body iron. Once enrolled in the present study, following Kenyan guidelines, women will receive standard prenatal care, including routine daily iron and folate supplementation. We will collect venous blood samples in each trimester and at delivery, and during the first 6 months of lactation in the mothers and infants (heel prick samples). To directly assess dietary iron absorption, in a randomly selected subset of women (n=35), oral and intravenous stable iron isotope tracers (54Fe, 58Fe) will be administered in the 2nd and 3rd trimesters.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Msambweni Referral Hospital

Msambweni, Kenya

Location status: Recruiting

Location contact

Edith Mwasi, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Providing consent to the informed consent form
  • Participation in a previous stable isotope absorption study and having received an oral dose of 15 mg 57Fe at least 12 months prior to the date of inclusion in the study
  • Positive pregnancy test and gestational age <10 weeks based on history of last menstrual period
  • Permanent residence in the study area, and not expected to leave the study site for more than 4 weeks over the following 16 months
  • Assessment of good health by professional staff at Msambweni Hospital

Exclusion criteria

  • Pre-pregnancy body mass index >30 kg/m2
  • Blood transfusion or intravenous iron treatment within 4 months of study start
  • Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis)
  • Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer)

Treatment and study plan

CO-rebreathing

Other

In the CO-rebreathing method, a dedicated apparatus is used for inhaling and rebreathing a very small bolus of CO through a spirometer for ~2 min, which is absorbed through the lungs and binds to Hb, and then the increase of HbCO content of blood is measured 8 min after the CO inhalation. The increase of COHb in blood samples can then be used to precisely calculate Hb mass and blood volume

Oral iron isotope administration (54Fe)

Other

Participants randomly assigned to the sub-group, will receive 54Fe with a test meal in the second and third trimester for assessment of dietary iron absorption

Intravenous iron isotope administration (58Fe)

Other

Participants randomly assigned to the sub-group, will receive intravenous 58Fe in the second and third trimester for assessment of erythrocyte iron incorporation

Primary outcomes

  1. Iron absorbed, lossed and gained in the first trimester

    Time frame: Change in 57Fe tracer abundance between gestational age 6, 10 and 15 weeks

    isotope dilution

  2. Iron absorbed, lossed and gained in the second trimester

    Time frame: Change in 57Fe tracer abundance between gestational age 15, 20 and 25 weeks

    isotope dilution

  3. Iron absorbed, lossed and gained in the third trimester

    Time frame: Change in 57Fe tracer abundance between gestational age 25, 30 and 35 weeks

    isotope dilution

  4. Iron absorbed, lossed and gained throughout pregnancy

    Time frame: Change in 57Fe tracer abundance between gestational age 6, 10, 15, 20, 25, 30 and 35 weeks

    isotope dilution

  5. Iron absorbed, lossed and gained in lactating women

    Time frame: Change in 57Fe tracer abundance between 6, 14 and 24 weeks postpartum

    isotope dilution

  6. Iron absorbed, lossed and gained in infancy

    Time frame: Change in 57Fe tracer abundance between age 6, 14 and 24 weeks

    isotope dilution

Secondary outcomes

  1. Fractional iron absorption (%) in the second trimester

    Time frame: gestational age 20 weeks

    shift in iron isotopic ratios

  2. Fractional iron absorption (%) in the third trimester

    Time frame: gestational age 30 weeks

    shift in iron isotopic ratios

  3. Erythrocyte iron incorporation (%) in the second trimester

    Time frame: gestational age 20 weeks

    shift in iron isotopic ratios

  4. Erythrocyte iron incorporation (%) in the third trimester

    Time frame: gestational age 30 weeks

    shift in iron isotopic ratios

  5. Hemoglobin concentration (g/dl)

    Time frame: gestational age 6 weeks

    Hb

  6. Hemoglobin concentration (g/dl)

    Time frame: gestational age 10 weeks

    Hb

  7. Hemoglobin concentration (g/dl)

    Time frame: gestational age 15 weeks

    Hb

  8. Hemoglobin concentration (g/dl)

    Time frame: gestational age 20 weeks

    Hb

  9. Hemoglobin concentration (g/dl)

    Time frame: gestational age 25 weeks

    Hb

  10. Hemoglobin concentration (g/dl)

    Time frame: gestational age 30 weeks

    Hb

  11. Hemoglobin concentration (g/dl)

    Time frame: gestational age 36 weeks

    Hb

  12. Hemoglobin concentration (g/dl)

    Time frame: 6 weeks postpartum

    mother

  13. Hemoglobin concentration (g/dl)

    Time frame: age 6 weeks

    infant

  14. Hemoglobin concentration (g/dl)

    Time frame: 14 weeks postpartum

    mother

  15. Hemoglobin concentration (g/dl)

    Time frame: age 14 weeks

    infant

  16. Hemoglobin concentration (g/dl)

    Time frame: 24 weeks postpartum

    mother

  17. Hemoglobin concentration (g/dl)

    Time frame: age 24 weeks

    infant

  18. Mean corpuscular volume (fl)

    Time frame: gestational age 6 weeks

    MCV

  19. Mean corpuscular volume (fl)

    Time frame: gestational age 10 weeks

    MCV

  20. Mean corpuscular volume (fl)

    Time frame: gestational age 20 weeks

    MCV

  21. Mean corpuscular volume (fl)

    Time frame: gestational age 30 weeks

    MCV

  22. Mean corpuscular volume (fl)

    Time frame: 6 weeks postpartum

    mother

  23. Mean corpuscular volume (fl)

    Time frame: age 6 weeks

    infant

  24. Mean corpuscular volume (fl)

    Time frame: 14 weeks postpartum

    mother

  25. Mean corpuscular volume (fl)

    Time frame: age 14 weeks

    infant

  26. Mean corpuscular volume (fl)

    Time frame: 24 weeks postpartum

    mother

  27. Mean corpuscular volume (fl)

    Time frame: age 24 weeks

    infant

  28. Erythropoietin concentration (mU/ml)

    Time frame: gestational age 10 weeks

    EPO

  29. Erythropoietin concentration (mU/ml)

    Time frame: gestational age 20 weeks

    EPO

  30. Erythropoietin concentration (mU/ml)

    Time frame: gestational age 30 weeks

    EPO

  31. Erythropoietin concentration (mU/ml)

    Time frame: 6 weeks postpartum

    EPO

  32. Erythropoietin concentration (mU/ml)

    Time frame: 14 weeks postpartum

    EPO

  33. Erythropoietin concentration (mU/ml)

    Time frame: 24 weeks postpartum

    EPO

  34. Erythroferrone concentration (ng/ml)

    Time frame: gestational age 10 weeks

    ERFE

  35. Erythroferrone concentration (ng/ml)

    Time frame: gestational age 20 weeks

    ERFE

  36. Erythroferrone concentration (ng/ml)

    Time frame: gestational age 30 weeks

    ERFE

  37. Erythroferrone concentration (ng/ml)

    Time frame: 6 weeks postpartum

    ERFE

  38. Erythroferrone concentration (ng/ml)

    Time frame: 14 weeks postpartum

    ERFE

  39. Erythroferrone concentration (ng/ml)

    Time frame: 24 weeks postpartum

    ERFE

  40. Hepcidin concentration (ng/ml)

    Time frame: gestational age 10 weeks

    Hep

  41. Hepcidin concentration (ng/ml)

    Time frame: gestational age 20 weeks

    Hep

  42. Hepcidin concentration (ng/ml)

    Time frame: gestational age 30 weeks

    Hep

  43. Hepcidin concentration (ng/ml)

    Time frame: 6 weeks postpartum

    Hep

  44. Hepcidin concentration (ng/ml)

    Time frame: 14 weeks postpartum

    Hep

  45. Hepcidin concentration (ng/ml)

    Time frame: 24 weeks postpartum

    Hep

  46. Serum ferritin concentration (ug/l)

    Time frame: gestational age 10 weeks

    SF

  47. Serum ferritin concentration (ug/l)

    Time frame: gestational age 20 weeks

    SF

  48. Serum ferritin concentration (ug/l)

    Time frame: gestational age 30 weeks

    SF

  49. Serum ferritin concentration (ug/l)

    Time frame: 6 weeks postpartum

    mother

  50. Serum ferritin concentration (ug/l)

    Time frame: age 6 weeks

    infant

  51. Serum ferritin concentration (ug/l)

    Time frame: 14 weeks postpartum

    mother

  52. Serum ferritin concentration (ug/l)

    Time frame: age 14 weeks

    infant

  53. Serum ferritin concentration (ug/l)

    Time frame: 24 weeks postpartum

    mother

  54. Serum ferritin concentration (ug/l)

    Time frame: age 24 weeks

    infant

  55. Soluble transferrin receptor concentration (ul/l)

    Time frame: gestational age 10 weeks

    sTfR

  56. Soluble transferrin receptor concentration (ul/l)

    Time frame: gestational age 20 weeks

    sTfR

  57. Soluble transferrin receptor concentration (ul/l)

    Time frame: gestational age 30 weeks

    sTfR

  58. Soluble transferrin receptor concentration (ul/l)

    Time frame: 6 weeks postpartum

    mother

  59. Soluble transferrin receptor concentration (ul/l)

    Time frame: age 6 weeks

    infant

  60. Soluble transferrin receptor concentration (ul/l)

    Time frame: 14 weeks postpartum

    mother

  61. Soluble transferrin receptor concentration (ul/l)

    Time frame: age 14 weeks

    infant

  62. Soluble transferrin receptor concentration (ul/l)

    Time frame: 24 weeks postpartum

    mother

  63. Soluble transferrin receptor concentration (ul/l)

    Time frame: age 24 weeks

    infant

  64. C-reactive protein concentration (mg/l)

    Time frame: gestational age 10 weeks

    CRP

  65. C-reactive protein concentration (mg/l)

    Time frame: gestational age 20 weeks

    CRP

  66. C-reactive protein concentration (mg/l)

    Time frame: gestational age 30 weeks

    CRP

  67. C-reactive protein concentration (mg/l)

    Time frame: 6 weeks postpartum

    mother

  68. C-reactive protein concentration (mg/l)

    Time frame: age 6 weeks

    infant

  69. C-reactive protein concentration (mg/l)

    Time frame: 14 weeks postpartum

    mother

  70. C-reactive protein concentration (mg/l)

    Time frame: age 14 weeks

    infant

  71. C-reactive protein concentration (mg/l)

    Time frame: 24 weeks postpartum

    mother

  72. C-reactive protein concentration (mg/l)

    Time frame: age 24 weeks

    infant

  73. alpha-glycoprotein concentration (mg/dl)

    Time frame: gestational age 10 weeks

    AGP

  74. alpha-glycoprotein concentration (mg/dl)

    Time frame: gestational age 20 weeks

    AGP

  75. alpha-glycoprotein concentration (mg/dl)

    Time frame: gestational age 30 weeks

    AGP

  76. alpha-glycoprotein concentration (mg/dl)

    Time frame: 6 weeks postpartum

    mother

  77. alpha-glycoprotein concentration (mg/dl)

    Time frame: age 6 weeks

    infant

  78. alpha-glycoprotein concentration (mg/dl)

    Time frame: 14 weeks postpartum

    mother

  79. alpha-glycoprotein concentration (mg/dl)

    Time frame: age 14 weeks

    infant

  80. alpha-glycoprotein concentration (mg/dl)

    Time frame: 24 weeks postpartum

    mother

  81. alpha-glycoprotein concentration (mg/dl)

    Time frame: age 24 weeks

    infant

  82. Blood volume (l)

    Time frame: gestational age 10 weeks

  83. Blood volume (l)

    Time frame: gestational age 20 weeks

    BV

  84. Blood volume (l)

    Time frame: gestational age 30 weeks

    BV

  85. Blood volume (l)

    Time frame: 6 weeks postpartum

    BV

  86. Blood volume (l)

    Time frame: 14 weeks postpartum

    BV

  87. Blood volume (l)

    Time frame: 24 weeks postpartum

    BV

  88. Intestinal fatty acid binding protein

    Time frame: gestational age 10 weeks

    I-FABP

  89. Intestinal fatty acid binding protein

    Time frame: gestational age 20 weeks

    I-FABP

  90. Intestinal fatty acid binding protein

    Time frame: gestational age 30 weeks

    I-FABP

  91. Retinol binding protein

    Time frame: gestational age 10 weeks

    RBP

  92. Retinol binding protein

    Time frame: gestational age 20 weeks

    RBP

  93. Retinol binding protein

    Time frame: gestational age 30 weeks

    RBP

  94. soluble CD14

    Time frame: gestational age 10 weeks

    sCD14

  95. soluble CD14

    Time frame: gestational age 20 weeks

    sCD14

  96. soluble CD14

    Time frame: gestational age 30 weeks

    sCD14

  97. Insulin-like growth factor 1

    Time frame: gestational age 10 weeks

    IGF-1

  98. Insulin-like growth factor 1

    Time frame: gestational age 20 weeks

    IGF-1

  99. Insulin-like growth factor 1

    Time frame: gestational age 30 weeks

    IGF-1

  100. Fibroblast growth factor 21

    Time frame: gestational age 10 weeks

    FGF21

  101. Fibroblast growth factor 21

    Time frame: gestational age 20 weeks

    FGF21

  102. Fibroblast growth factor 21

    Time frame: gestational age 30 weeks

    FGF21

Study contacts

Contact information is provided by the study sponsor or research team.

Joyce Wali, BSc

CONTACT

[email protected]

+254704862877

Nicole Stoffel, PhD

CONTACT

[email protected]

+41446328393

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Columbia University
  • ETH Zurich
  • Jomo Kenyatta University of Agriculture and Technology
  • Msambweni County Referral Hospital

Registry information

Official study title

Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women

Acronym: PILLAR_II

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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