Long-term Iron Absorption and Loss in Women

NCT07855939 | Recruiting

• 1 other identifier: C00NU66050024
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Obese people typically have chronic low-grade inflammation. Based on short-term studies, this inflammation could affect the absorption, utilization, storage, and mobilization of iron, and individuals with inflammation might develop iron deficiency (ID) and anemia when inadequacy of iron intake is presented. The double burden of malnutrition is nowadays emerging as a major public health concern in many countries, including Thailand. Understanding the association of chronic inflammation among people with overweight or obesity (OW/OB) with long-term iron absorption and loss is important for developing appropriate policies and programs to promote iron balance and, consequently, optimal iron status and health outcomes. Since previous reports among Thai women showed a high prevalence of OW/OB and anemia, this study will be conducted to determine the long-term iron absorption and loss among OW/OB free-living women using the iron isotope dilution method.

Conditions

Obesity & Overweight; Normal Weight Adults

Keywords

low-grade chronic inflammation; long-term iron absorption and loss; Iron isotope

Outcome Measures

Primary Outcomes (3)

• Mean long-term iron absorption (Fe abs)

  Calculated over the duration of the study as follows: Fe abs = k abs x Fe total Where Fe total is the total body iron at the midpoint, calculated from the linear regression of Fe total versus time across each measurement point; and k abs is the fraction of total body iron absorbed per unit of time (derived from the slope of the linear regression equation of ln 57 Fe versus time). 57 Fe isotope will be measured using Inductively Coupled Plasma Mass Spectrometry (ICP-MS).

  Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24).

• Mean long-term iron loss (Fe loss)

  Calculated in the same manner as iron absorption: Fe loss = k loss x Fe total Where k loss is the fraction of total body iron lost per unit of time.

  Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)

• Iron gain (Fe gain)

  Calculated as net iron balance: Fe gain = Fe abs - Fe loss

  Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)

Secondary Outcomes (14)

• Weight (kg)

  Visit 1 (Screening), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)

• Height (cm)

  Visit 1 (Screening)

• Body Mass Index (BMI, kg/m²)

  Visit 1 (Screening), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)

• Body composition (fat mass)

  Visit 1 (Screening), Visit 4 (after 1 year; WK0), Visits 7 (WK24)

• Nutrient intakes

  Visit 2 (Month 0), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)

Study Arms (2)

Normal weight

BMI 18.5-22.9 kg/m2

Overweight or obesity

BMI 25-35 kg/m2

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 64 women aged 40-50 years, divided into two groups: 32 participants who are overweight or obese, and 32 participants with normal weight.

You may qualify if:

• Normal weight group
• Aged 40-50 years
• Normal weight (BMI 18.5-22.9 kg/m²)
• Hb ≥12.0 g/dL and inflammation-adjusted SFa \<50.0 µg/L
• CRP \<5.0 mg/L
• Normal hemoglobin typing
• Plans to reside in the study area for \>2 years
• Overweight/obese group
• Aged 40-50 years
• Overweight or obese \[Body Mass Index (BMI) ≥25.0 kg/m²\] - the BMI cut-off follows the agreement of countries under the Coordinated Research Project (CRP) E43038 "Using the iron isotope dilution technique to assess the influence of inflammation on long-term iron absorption and loss," supported by the IAEA
• Hemoglobin (Hb) ≥12.0 g/dL and inflammation-adjusted serum ferritin (SFa) \<50.0 µg/L
• C-reactive protein (CRP) between 5.0-25.0 mg/L
• Normal hemoglobin typing
• Plans to reside in the study area for \>2 years

You may not qualify if:

• Normal weight group
• Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure
• Having metabolic NCDs (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization
• Pregnant, breastfeeding, or planning pregnancy during the study
• Chronic infectious disease (e.g., tuberculosis, AIDS)
• Regular use of anti-inflammatory or other medications (except contraceptives and acne medication)
• Taking vitamin or mineral supplements during or within two weeks prior to the study
• Participating in a weight-loss program
• Known intolerance to iron supplements (e.g., vomiting, diarrhea, abdominal pain, bloating, nausea, or allergic reactions such as rash, breathing difficulty, chest tightness, facial or lip swelling)
• Blood transfusion, blood donation, or significant blood loss during the study or within 6 months before enrollment
• Heavy menstrual bleeding (\>80 mL/day, calculated from menstrual record)
• Overweight/obese group
• Obesity class II (BMI ≥35.0 kg/m²) with high health risk
• Having serious medical conditions such as cancer, chronic kidney disease, chronic liver disease, or chronic heart failure
• Having metabolic noncommunicable diseases (e.g., diabetes, hyperlipidemia, hypertension) requiring hospitalization

Sponsors & Collaborators

• Mahidol University: lead
• International Atomic Energy Agency: collaborator

Study Sites (1)

Institute of Nutrition

Nakhon Pathom, 73170, Thailand

RECRUITING

Related Publications (8)

• International Atomic Energy Agency (IAEA). Assessment of iron bioavailability in humans using stable iron isotope techniques. IAEA Human Health Series No.21, Vienna 2021. Available at https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1544_web.pdf.

  BACKGROUND

• Stoffel NU, Cercamondi CI, Brittenham G, Zeder C, Geurts-Moespot AJ, Swinkels DW, Moretti D, Zimmermann MB. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017 Nov;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5. Epub 2017 Oct 9.

  PMID: 29032957 BACKGROUND

• Speich C, Mitchikpe CES, Cercamondi CI, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Direct assessment of body iron balance in women with and without iron supplementation using a long-term isotope dilution method in Benin and Switzerland. Am J Clin Nutr. 2021 Jun 1;113(6):1657-1669. doi: 10.1093/ajcn/nqaa433.

  PMID: 33693464 BACKGROUND

• Zimmermann MB, Zeder C, Muthayya S, Winichagoon P, Chaouki N, Aeberli I, Hurrell RF. Adiposity in women and children from transition countries predicts decreased iron absorption, iron deficiency and a reduced response to iron fortification. Int J Obes (Lond). 2008 Jul;32(7):1098-104. doi: 10.1038/ijo.2008.43. Epub 2008 Apr 22.

  PMID: 18427564 BACKGROUND

• Luciani N, Brasse-Lagnel C, Poli M, Anty R, Lesueur C, Cormont M, Laquerriere A, Folope V, LeMarchand-Brustel Y, Gugenheim J, Gual P, Tran A, Bekri S. Hemojuvelin: a new link between obesity and iron homeostasis. Obesity (Silver Spring). 2011 Aug;19(8):1545-51. doi: 10.1038/oby.2011.12. Epub 2011 Feb 10.

  PMID: 21311510 BACKGROUND

• Cepeda-Lopez AC, Aeberli I, Zimmermann MB. Does obesity increase risk for iron deficiency? A review of the literature and the potential mechanisms. Int J Vitam Nutr Res. 2010 Oct;80(4-5):263-70. doi: 10.1024/0300-9831/a000033.

  PMID: 21462109 BACKGROUND

• Cepeda-Lopez AC, Osendarp SJ, Melse-Boonstra A, Aeberli I, Gonzalez-Salazar F, Feskens E, Villalpando S, Zimmermann MB. Sharply higher rates of iron deficiency in obese Mexican women and children are predicted by obesity-related inflammation rather than by differences in dietary iron intake. Am J Clin Nutr. 2011 May;93(5):975-83. doi: 10.3945/ajcn.110.005439. Epub 2011 Mar 16.

  PMID: 21411619 BACKGROUND

• Gonzalez-Dominguez A, Visiedo-Garcia FM, Dominguez-Riscart J, Gonzalez-Dominguez R, Mateos RM, Lechuga-Sancho AM. Iron Metabolism in Obesity and Metabolic Syndrome. Int J Mol Sci. 2020 Aug 1;21(15):5529. doi: 10.3390/ijms21155529.

  PMID: 32752277 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica LOPEZ TEROS, Ph.D.

  Internation Atomic Energy Agency

  STUDY DIRECTOR

Central Study Contacts

Tippawan Pongcharoen, Ph.D.

CONTACT

+66813749901; tippawan.pon@mahidol.ac.th

Aree Prachansuwan, Ph.D.

CONTACT

+66890060602

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: October 2, 2026
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

TH (1)