Iron-deficiency
Conditions
Brief summary
Iron is very important for our body and performs vital tasks. Iron deficiency is a worldwide health problem. The prevalence of anemia in women of reproductive age in Southeast Asia is estimated to be 46.6% in 2019, with iron deficiency being one of the main reasons for anemia. There are different approaches to treat iron deficiency. One of them is the use of iron supplements. Recommended iron supplement treatments today often differ in dose, regimen and length. Experts recommend a dose of 80-200 mg of iron taken either daily or on several days per week, depending on the severity of the iron deficiency (with or without anemia). From certain guidelines lower amounts of iron are also recommended, as this could lead to fewer side effects.Previous studies have shown that both daily and multiple days per week administration can be effective in treating iron deficiency. Recently, several successive iron supplementation studies in Zurich showed that 24 h after ingestion of an oral dose of \>60mg iron, the absorption of iron in the body is impaired. In addition it was measured that iron supplements taken only every other day instead of every day are absorbed about 30-50% better and have fewer side effects. Little is known about the long-term effect of this alternating regimen on iron status and side effects.With this 6-months study in the Philippines, the investigators want to compare two different supplementation regimens with oral iron to see if there is any difference in the iron status, intestinal inflammation levels, and side effects, and therefore if it would be better to take the iron supplements every 2 days instead of daily.
Interventions
DIETARY_SUPPLEMENTdaily ferrous sulfate
Daily intake of 100 mg ferrous sulfate capsules for 3 months
DIETARY_SUPPLEMENTalternate day ferrous sulfate
Alternate day intake of 100 mg ferrous sulfate capsules for 6 months
Sponsors
St. Luke's Medical Center
University of Oxford
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and investigators are blinded, double blind study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female, 18 to 45 years old, * SF levels \<25 µg/L, * Hb levels 11-15.5 g/dL * Normal Body Mass Index (18.5-25 kg/m2), * In possession of a mobile phone on which the study app can be loaded * Signed informed consent
Exclusion criteria
* Elevated CRP \> 5 mg/L * Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) affecting iron metabolism, * Use of medication which may interfere with iron absorption, gut physiology and iron metabolism * Consumption of iron supplements within 2 weeks prior to study start and of additional iron supplements during the study period * Difficulties with blood sampling, * Known hypersensitivity or allergy to iron or placebo capsules in the given amount (ferrous sulfate, mannitol, silica) * Pregnancy, breastfeeding * Known or suspected non-compliance, drug or alcohol abuse * Cigarette smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin (SF) | Day 93 | in consecutive day group |
| Event rate of GI side effects | Day 90 | in consecutive day group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Transferrin Receptor (sTfR) | Day 0 | — |
| Total iron binding capacity (TIBC) | Day 0 | — |
| Serum Iron (SFe) | Day 0 | — |
| C-Reactive Protein (CRP) | Day 0 | — |
| Alpha-1-acid Glycoprotein (AGP) | Day 0 | — |
| Intestinal Fatty Acid-binding Protein (I-FABP) | Day 0 | — |
| Hemoglobin (Hb) | Day 0 | — |
| Hepcidin | Day 0 | — |
| Event rate of GI side effects | Day 90 | — |
| Incidence of GI side effects | Day 90 | — |
| Event proportion of GI side effects | Day 90 | — |
| Severity of GI side effects | Day 90 | 5 different side effects (nausea, stomach pain, constipation, diarrhea, bloating) are reported if they occur in a study app and rated mild or severe, according to their judgement. |
| Calprotectin | Day 0 | — |
| Serum Ferritin (SF) | Day 0 | — |
Countries
Philippines
Outcome results
None listed