Clinical trial NCT05280821: Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women in the Philippines
Official title: Comparing Oral Iron Supplementation Using Alternate-day Dosing to the Standard of Care Consecutive-day Dosing in Iron-depleted Women With or Without Mild Anemia: a Randomized Controlled Trial in the Philippines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Iron-deficiency
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: St. Luke's Medical Center
name: University of Oxford
First posted: 2022-03-15
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum Ferritin (SF)
timeFrame: Day 93
measure: Serum Ferritin (SF)
timeFrame: Day 186
measure: Event rate of GI side effects
timeFrame: Day 90
measure: Event rate of GI side effects
timeFrame: Day 183
Secondary outcomes:
measure: Hemoglobin (Hb)
timeFrame: Day 0
measure: Hemoglobin (Hb)
timeFrame: Day 46
measure: Hemoglobin (Hb)
timeFrame: Day 93
measure: Hemoglobin (Hb)
timeFrame: Day 139
measure: Hemoglobin (Hb)
timeFrame: Day 183
measure: Serum Ferritin (SF)
timeFrame: Day 0
measure: Serum Ferritin (SF)
timeFrame: Day 46
measure: Serum Ferritin (SF)
timeFrame: Day 93
measure: Serum Ferritin (SF)
timeFrame: Day 139
measure: Serum Ferritin (SF)
timeFrame: Day 186
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 0
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 46
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 93
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 139
measure: Serum Transferrin Receptor (sTfR)
timeFrame: Day 186
measure: Total iron binding capacity (TIBC)
timeFrame: Day 0
measure: Total iron binding capacity (TIBC)
timeFrame: Day 93
measure: Total iron binding capacity (TIBC)
timeFrame: Day 186
measure: Serum Iron (SFe)
timeFrame: Day 0
measure: Serum Iron (SFe)
timeFrame: Day 93
measure: Serum Iron (SFe)
timeFrame: Day 186
measure: C-Reactive Protein (CRP)
timeFrame: Day 0
measure: C-Reactive Protein (CRP)
timeFrame: Day 46
measure: C-Reactive Protein (CRP)
timeFrame: Day 93
measure: C-Reactive Protein (CRP)
timeFrame: Day 139
measure: C-Reactive Protein (CRP)
timeFrame: Day 186
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 0
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 46
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 93
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 139
measure: Alpha-1-acid Glycoprotein (AGP)
timeFrame: Day 186
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 0
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 90
measure: Intestinal Fatty Acid-binding Protein (I-FABP)
timeFrame: Day 183
measure: Calprotectin
timeFrame: Day 0
measure: Calprotectin
timeFrame: Day 90
measure: Calprotectin
timeFrame: Day 183
measure: Hepcidin
timeFrame: Day 0
measure: Hepcidin
timeFrame: Day 46
measure: Hepcidin
timeFrame: Day 90
measure: Hepcidin
timeFrame: Day 139
measure: Hepcidin
timeFrame: Day 183
measure: Event rate of GI side effects
timeFrame: Day 90
measure: Event rate of GI side effects
timeFrame: Day 183
measure: Incidence of GI side effects
timeFrame: Day 90
measure: Incidence of GI side effects
timeFrame: Day 183
measure: Event proportion of GI side effects
timeFrame: Day 90
measure: Event proportion of GI side effects
timeFrame: Day 183
measure: Severity of GI side effects
timeFrame: Day 90
measure: Severity of GI side effects
timeFrame: Day 183
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
state: Metro Manila
Study officials:
References: