Long-term Iron Absorption and Loss in Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-50
SponsorMahidol University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
64 Participants
are grouped into 2 trial groupsGroup A: Normal weight
Group B: Overweight or obesity
Trial outcomes
Primary outcomes
1
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).
Time frame
Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24).2
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.
Time frame
Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)3
Iron gain (Fe gain)
Calculated as net iron balance: Fe gain = Fe abs - Fe loss
Time frame
Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)Secondary outcomes
1
Weight (kg)
Weight will be measured in kg (to the nearest 0.1 kg) using an Inbody digital weighing scale.
Time frame
Visit 1 (Screening), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)2
Height (cm)
Height will be measured to the mearest 0.1 cm using a Harpenden stadiometer.
Time frame
Visit 1 (Screening)3
Body Mass Index (BMI, kg/m²)
BMI will be calculatedn body weight in kilograms divided by height in meters squared.
Time frame
Visit 1 (Screening), Visit 3 (Month 9), Visit 4 (after 1 year; WK0), Visits 5-7 (WK8, WK16, WK24)4
Body composition (fat mass)
Body composition (fat mass) will be measured using the Bioelectrical Impedance Analyzer (BIA; InBody).
Time frame
Visit 1 (Screening), Visit 4 (after 1 year; WK0), Visits 7 (WK24)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mahidol University
Lead sponsor
International Atomic Energy Agency
Collaborator
Source ClinicalTrials.gov