Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women in the Philippines

Swiss Federal Institute of Technology22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Interventions

daily ferrous sulfateDIETARY_SUPPLEMENT

Daily intake of 100 mg ferrous sulfate capsules for 3 months

alternate day ferrous sulfateDIETARY_SUPPLEMENT

Alternate day intake of 100 mg ferrous sulfate capsules for 6 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Santo Tomas Hospital

Manila, National Capital Region, Philippines

Outcomes

Primary Outcomes

Serum Ferritin (SF)

in consecutive day group

Time frame: Day 93

Serum Ferritin (SF)

in alternate day group

Time frame: Day 186

Event rate of GI side effects

in consecutive day group

Time frame: Day 90

Event rate of GI side effects

in alternate day group

Time frame: Day 183

Secondary Outcomes

Hemoglobin (Hb)

Time frame: Day 0

Hemoglobin (Hb)

Time frame: Day 46

Hemoglobin (Hb)

Time frame: Day 93

Hemoglobin (Hb)

Time frame: Day 139

Hemoglobin (Hb)

Time frame: Day 183

Serum Ferritin (SF)

Time frame: Day 0

Serum Ferritin (SF)

Time frame: Day 46

Serum Ferritin (SF)

Time frame: Day 93

Serum Ferritin (SF)

Time frame: Day 139

Serum Ferritin (SF)

Time frame: Day 186

Serum Transferrin Receptor (sTfR)

Time frame: Day 0

Serum Transferrin Receptor (sTfR)

Time frame: Day 46

Serum Transferrin Receptor (sTfR)

Time frame: Day 93

Serum Transferrin Receptor (sTfR)

Time frame: Day 139

Serum Transferrin Receptor (sTfR)

Time frame: Day 186

Total iron binding capacity (TIBC)

Time frame: Day 0

Total iron binding capacity (TIBC)

Time frame: Day 93

Total iron binding capacity (TIBC)

Time frame: Day 186

Serum Iron (SFe)

Time frame: Day 0

Serum Iron (SFe)

Time frame: Day 93

Serum Iron (SFe)

Time frame: Day 186

C-Reactive Protein (CRP)

Time frame: Day 0

C-Reactive Protein (CRP)

Time frame: Day 46

C-Reactive Protein (CRP)

Time frame: Day 93

C-Reactive Protein (CRP)

Time frame: Day 139

C-Reactive Protein (CRP)

Time frame: Day 186