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

NCT ID: NCT05280821

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2022-11-19

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.

Conditions

Iron-deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Consecutive Day Dosing

This arm will daily receive iron capsules for 3 months, followed by daily placebo capsules for 3 months.

Group Type: ACTIVE_COMPARATOR

daily ferrous sulfate

Intervention Type: DIETARY_SUPPLEMENT

Daily intake of 100 mg ferrous sulfate capsules for 3 months

Alternate Day Dosing

This arm will receive iron capsules alternating with placebo capsules for 6 months.

Group Type: EXPERIMENTAL

alternate day ferrous sulfate

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

daily ferrous sulfate

Daily intake of 100 mg ferrous sulfate capsules for 3 months

Intervention Type: DIETARY_SUPPLEMENT

alternate day ferrous sulfate

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

St. Luke's Medical Center

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Santo Tomas Hospital

Manila, National Capital Region, Philippines

Countries

Philippines

Other Identifiers

CAPS_PH

Identifier Type: -

Identifier Source: org_study_id