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

Iron-deficiency Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05280821
• Other study ID #: CAPS_PH
• Status: Terminated
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: November 19, 2022

Study information

• Verified date: January 2024
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: November 19, 2022
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Iron-deficiency

Intervention

Dietary Supplement:
• daily ferrous sulfate
Daily intake of 100 mg ferrous sulfate capsules for 3 months
• alternate day ferrous sulfate
Alternate day intake of 100 mg ferrous sulfate capsules for 6 months

Locations

Country	Name	City	State
Philippines	University of Santo Tomas Hospital	Manila	Metro Manila

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	St. Luke's Medical Center, University of Oxford

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Ferritin (SF)	in consecutive day group	Day 93
Primary	Serum Ferritin (SF)	in alternate day group	Day 186
Primary	Event rate of GI side effects	in consecutive day group	Day 90
Primary	Event rate of GI side effects	in alternate day group	Day 183
Secondary	Hemoglobin (Hb)		Day 0
Secondary	Hemoglobin (Hb)		Day 46
Secondary	Hemoglobin (Hb)		Day 93
Secondary	Hemoglobin (Hb)		Day 139
Secondary	Hemoglobin (Hb)		Day 183
Secondary	Serum Ferritin (SF)		Day 0
Secondary	Serum Ferritin (SF)		Day 46
Secondary	Serum Ferritin (SF)		Day 93
Secondary	Serum Ferritin (SF)		Day 139
Secondary	Serum Ferritin (SF)		Day 186
Secondary	Serum Transferrin Receptor (sTfR)		Day 0
Secondary	Serum Transferrin Receptor (sTfR)		Day 46
Secondary	Serum Transferrin Receptor (sTfR)		Day 93
Secondary	Serum Transferrin Receptor (sTfR)		Day 139
Secondary	Serum Transferrin Receptor (sTfR)		Day 186
Secondary	Total iron binding capacity (TIBC)		Day 0
Secondary	Total iron binding capacity (TIBC)		Day 93
Secondary	Total iron binding capacity (TIBC)		Day 186
Secondary	Serum Iron (SFe)		Day 0
Secondary	Serum Iron (SFe)		Day 93
Secondary	Serum Iron (SFe)		Day 186
Secondary	C-Reactive Protein (CRP)		Day 0
Secondary	C-Reactive Protein (CRP)		Day 46
Secondary	C-Reactive Protein (CRP)		Day 93
Secondary	C-Reactive Protein (CRP)		Day 139
Secondary	C-Reactive Protein (CRP)		Day 186
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 0
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 46
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 93
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 139
Secondary	Alpha-1-acid Glycoprotein (AGP)		Day 186
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 0
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 90
Secondary	Intestinal Fatty Acid-binding Protein (I-FABP)		Day 183
Secondary	Calprotectin		Day 0
Secondary	Calprotectin		Day 90
Secondary	Calprotectin		Day 183
Secondary	Hepcidin		Day 0
Secondary	Hepcidin		Day 46
Secondary	Hepcidin		Day 90
Secondary	Hepcidin		Day 139
Secondary	Hepcidin		Day 183
Secondary	Event rate of GI side effects		Day 90
Secondary	Event rate of GI side effects		Day 183
Secondary	Incidence of GI side effects		Day 90
Secondary	Incidence of GI side effects		Day 183
Secondary	Event proportion of GI side effects		Day 90
Secondary	Event proportion of GI side effects		Day 183
Secondary	Severity of GI side effects	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.	Day 90
Secondary	Severity of GI side effects	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.	Day 183