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Iron-deficiencyNCT05280821

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

A study testing daily ferrous sulfate and alternate day ferrous sulfate in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Philippines.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Iron-deficiency
What is being tested?
daily ferrous sulfate and alternate day ferrous sulfate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePhilippines
Study dates
6 Apr 2022to 19 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Pregnancy, breastfeeding
  • Known or suspected non-compliance, drug or alcohol abuse
  • Cigarette smokers

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • University of Santo Tomas Hospital

    Manila, National Capital Region, 1015

Other trials in Philippines

About this study

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

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
Being tested
daily ferrous sulfate, alternate day ferrous sulfate
Medical subject headings
Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05280821
Study groupRoleWhat they receive
Consecutive Day DosingActive comparatorThis arm will daily receive iron capsules for 3 months, followed by daily placebo capsules for 3 months.
Receives: Dietary Supplement: daily ferrous sulfate
Alternate Day DosingExperimentalThis arm will receive iron capsules alternating with placebo capsules for 6 months.
Receives: Dietary Supplement: alternate day ferrous sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Ferritin (SF)

    in consecutive day group

    Measured: Day 93

  2. Serum Ferritin (SF)

    in alternate day group

    Measured: Day 186

  3. Event rate of GI side effects

    in consecutive day group

    Measured: Day 90

  4. Event rate of GI side effects

    in alternate day group

    Measured: Day 183

Secondary outcomes (50)

  1. Hemoglobin (Hb)

    Measured: Day 0

  2. Hemoglobin (Hb)

    Measured: Day 46

  3. Hemoglobin (Hb)

    Measured: Day 93

  4. Hemoglobin (Hb)

    Measured: Day 139

  5. Hemoglobin (Hb)

    Measured: Day 183

  6. Serum Ferritin (SF)

    Measured: Day 0

  7. Serum Ferritin (SF)

    Measured: Day 46

  8. Serum Ferritin (SF)

    Measured: Day 93

  9. Serum Ferritin (SF)

    Measured: Day 139

  10. Serum Ferritin (SF)

    Measured: Day 186

  11. Serum Transferrin Receptor (sTfR)

    Measured: Day 0

  12. Serum Transferrin Receptor (sTfR)

    Measured: Day 46

  13. Serum Transferrin Receptor (sTfR)

    Measured: Day 93

  14. Serum Transferrin Receptor (sTfR)

    Measured: Day 139

  15. Serum Transferrin Receptor (sTfR)

    Measured: Day 186

  16. Total iron binding capacity (TIBC)

    Measured: Day 0

  17. Total iron binding capacity (TIBC)

    Measured: Day 93

  18. Total iron binding capacity (TIBC)

    Measured: Day 186

  19. Serum Iron (SFe)

    Measured: Day 0

  20. Serum Iron (SFe)

    Measured: Day 93

  21. Serum Iron (SFe)

    Measured: Day 186

  22. C-Reactive Protein (CRP)

    Measured: Day 0

  23. C-Reactive Protein (CRP)

    Measured: Day 46

  24. C-Reactive Protein (CRP)

    Measured: Day 93

  25. C-Reactive Protein (CRP)

    Measured: Day 139

  26. C-Reactive Protein (CRP)

    Measured: Day 186

  27. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 0

  28. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 46

  29. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 93

  30. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 139

  31. Alpha-1-acid Glycoprotein (AGP)

    Measured: Day 186

  32. Intestinal Fatty Acid-binding Protein (I-FABP)

    Measured: Day 0

  33. Intestinal Fatty Acid-binding Protein (I-FABP)

    Measured: Day 90

  34. Intestinal Fatty Acid-binding Protein (I-FABP)

    Measured: Day 183

  35. Calprotectin

    Measured: Day 0

  36. Calprotectin

    Measured: Day 90

  37. Calprotectin

    Measured: Day 183

  38. Hepcidin

    Measured: Day 0

  39. Hepcidin

    Measured: Day 46

  40. Hepcidin

    Measured: Day 90

  41. Hepcidin

    Measured: Day 139

  42. Hepcidin

    Measured: Day 183

  43. Event rate of GI side effects

    Measured: Day 90

  44. Event rate of GI side effects

    Measured: Day 183

  45. Incidence of GI side effects

    Measured: Day 90

  46. Incidence of GI side effects

    Measured: Day 183

  47. Event proportion of GI side effects

    Measured: Day 90

  48. Event proportion of GI side effects

    Measured: Day 183

  49. 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.

    Measured: Day 90

  50. 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.

    Measured: Day 183

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start6 Apr 2022
  3. Primary completion19 Nov 2022
  4. Study completion19 Nov 2022

Why it stopped: insufficient recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280821
Sponsor's protocol ID
CAPS_PH
Status last verified
Jan 2024
First submitted
23 Feb 2022
Last updated
25 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing daily ferrous sulfate and alternate day ferrous sulfate in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Ferritin (SF) (time frame: Day 93). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.

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