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AnemiaNCT05682261

The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age

A study testing UNIMMAP-MMS and IFA in people with Anemia, run by Ethiopian Public Health Institute at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to test the effect of multiple micronutrient supplements in reducing anemia in women of reproductive age in comparison with iron-folic acid. The main questions it aims to answer are: What is the effect of multiple micronutrient supplements in reducing anemia among women of… Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Anemia
What is being tested?
UNIMMAP-MMS and IFA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
1 siteEthiopia
Study dates
23 Mar 2023to 17 Oct 2023
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 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age range of 18-49 years.
  • Mildly anemic (Hb=11.0-11.9 g/dl) or moderately anemic (Hb=8.0-10.9 g/dl) woman
  • Permanent residents (lived for at least six months in the enumeration area)

Who cannot join

  • A woman whose age is below or above the age range 18-49 year
  • A pregnant woman
  • Severely ill and incapacitated woman
  • Non-permanent resident in the enumeration area
  • Severely anemic (Hb <8.0 g/dl) woman
  • A woman with Hb ≥12 g/dl

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site
  • Ethiopian Public Health Institute

    Addis Ababa, Addis Ababa, 1242

Other trials in Ethiopia

About this study

Official title: The Effect of Multiple Micronutrient Supplements in Reducing Anemia Among Women of Reproductive Age Compared to Iron-folic Acid at Kebribeyah District in Somali Regional State, Ethiopia- A Community-based Individual Randomized Control Trial

The goal of this clinical trial is to test the effect of multiple micronutrient supplements in reducing anemia in women of reproductive age in comparison with iron-folic acid.

The main questions it aims to answer are:

Read more
  • What is the effect of multiple micronutrient supplements in reducing anemia among women of reproductive age in comparison with iron-folic acid?
  • What is the effect of multiple micronutrient supplements in reducing iron deficiency among women of reproductive age in comparison with iron-folic acid?

Participants will

  • be given multiple micronutrient supplements, iron folic acid, or placebo twice weekly for 17 weeks
  • be asked to respond to the interview
  • provide blood, urine, and stool samples

Researchers will compare the control group with the intervention groups to see the effect of multiple micronutrient supplements on iron deficiency and anemia reduction.

Read the detailed description

Women in developing countries are often at risk of micronutrient deficiencies due to inadequate micronutrient intake. Since various micronutrient deficiencies co-exist, multiple micronutrient supplements are recommended to combat their deficiencies. The purpose of this study is to assess the effects of multiple micronutrient supplements among women of reproductive age in reducing anemia compared with iron-folic acid as currently practiced in Ethiopia. The current study is a community-based individual randomized placebo-controlled trial. The trial is double blinded with three parallel groups. This trial will be conducted in three randomly selected kebeles (villages) in the Kebribeyah district in the Somali regional state. The sample size determined for this study is 305. There will be two intervention arms and one control arm in this trial. A third of participants will be in each arms. The intervention arms will will be supplemented with United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) or iron-folic acid (IFA) and the control arm with placebos twice a week. The investigators will follow the study participants for 17 weeks. The primary outcome is a change in mean hemoglobin concentrations and reduction in anemia prevalence. Stratified randomization will be used to assign the participants randomly to the study arms. In the current trial, the outcome assessors and study subjects will both be blinded. The supplements being administered to participants, as well as who is in the intervention group and who is in the control group, will be masked from the assessors. The trial participants will be blinded to the kind of supplements being administered to them or the group to which they were assigned. The allocation sequence of participants will be concealed from the researcher who will assign the participants to the study arms. When the eligible woman meets the screening criteria and gives informed consent, she will be assigned an envelope that contains an allocation sequence. As outcome measures, the investigators will assess the reduction in overall anemia and iron deficiency anemia attributable to the supplementation. In addition, a complete blood count (CBC) will be tested for all study participants.

Conditions
Anemia
Being tested
UNIMMAP-MMS, IFA, Placebo
Keywords
Multiple Micronutrient Supplements, Iron-folic acid, Anemia, Hemoglobin, Women of reproductive age
Medical subject headings
Anemia

What participants receive

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

  • UNIMMAP-MMSDietary supplement

    The study participants in this arm will receive the United Nations International Multiple Micronutrient Antenatal Preparation-Multiple Micronutrient Supplements (UNIMMAP-MMS) containing 15 micronutrients including 30 mg of iron and 400 µg of folic acid.

  • IFADietary supplement

    The study participants in this arm will receive iron-folic acid supplements with 30 mg of iron and 400 µg of folic acid.

  • PlaceboOther

    The study participants in this arm will receive placebo made of sugar (lactose anhydrous).

Study groups in NCT05682261
Study groupRoleWhat they receive
Multiple micronutrient supplement armExperimentalThe participants in this arm will receive United Nations International Multiple Micronutrient-Multiple Micronutrient Supplements. The recommended doses of UNIMMAP-MMS are vitamin A as retinol acetate (800 µg RAE), vitamin D as cholecalciferol (5 µg), vitamin E as alpha-tocopherol succinate (10 mg), vitamin C as ascorbic acid (70 mg), vitamin B1 as thiamin mononitrate (1.4 mg), vitamin B2 as riboflavin (1.4 mg), vitamin B3 as nicotinamide (18 mg), vitamin B6 as pyridoxine hydrochloride (1.9 mg), vitamin B12 as cyanocobalamin (2.6 µg), folic acid (680 µg), iron as ferrous fumarate (30 mg), zinc as zinc oxide (15 mg), copper as copper oxide (2 mg), selenium as sodium selenite (65 µg), iodine as potassium iodide (150 µg). The UNIMMAP-MMS in the tablet form will be used. We will give the supplementation twice a week and follow the study participants for 17 weeks.
Receives: Dietary Supplement: UNIMMAP-MMS
Iron-folic acid supplement armExperimentalThe participants in this arm will receive Iron-Folic Acid (IFA) supplements. The recommended doses of iron-folic acid are 30-60 mg of elemental iron and 400 µg of folic acid combined. In this trial, we will use ferrous sulfate with 30 mg of iron and 400 µg of folic acid in the form of capsule. The supplementation will be given to the study subjects twice a week for 17 weeks.
Receives: Dietary Supplement: IFA
Control armPlacebo comparatorThe participants in this arm will receive placebos made of sugar (lactose anhydrous). There is no active ingredient in the placebos. The placebos are lactose powder filled in the capsule. We will give placebos twice a week and will follow the study subjects for 17 weeks. The study subjects in this arm will be compensated with UNIMMAP-MMS at the end of the intervention.
Receives: Other: Placebo

What is being measured

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

  1. Change in mean hemoglobin concentrations among women of reproductive age

    Hemoglobin concentration is measured in gram/deciliter from whole blood samples collected at baseline and end-line.

    Measured: Blood sample will be collected once at baseline and once at end-line in four months

  2. Change in overall anemia among women of reproductive age

    Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl

    Measured: Blood sample will be collected once at baseline and once at end-line in four months

Secondary outcomes (2)
  1. Change in mean ferritin concentration among women of reproductive age

    Ferritin concentration is measured from serum ferritin in µg/L.

    Measured: The serum samples will be collected once at the baseline and once at the end-line in four months

  2. Change in iron deficiency anemia among women of reproductive age

    Iron deficiency anemia is diagnosed when hemoglobin concentration test result is less than 12 g/dl and the ferritin concentration test result is less than 15 µg/L

    Measured: Blood sample will be collected once at baseline and once at end-line in four months

Timeline

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

  1. First posted12 Jan 2023
  2. Study start23 Mar 2023
  3. Primary completion17 Oct 2023
  4. Study completion17 Oct 2023

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
Model description
The three arms included in this trial are the multiple micronutrient supplement arm, iron-folic acid arm, and the placebo arm. This trial is a parallel-group community-based individual randomized control trial. The participants will be allocated randomly to the three arms and receive only the intervention assigned to them.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05682261
Sponsor's protocol ID
EPHI_IRB_410_2021_2
Status last verified
Sep 2023
First submitted
4 Dec 2022
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not currently have any plans to provide access to individual participant data. We may share the data once the key findings have been published. In addition, we need to obtain approval from the officials of the Ethiopian Public Health Institute.

Publications

  • Chaparro CM, Suchdev PS. Anemia epidemiology, pathophysiology, and etiology in low- and middle-income countries. Ann N Y Acad Sci. 2019 Aug;1450(1):15-31. doi: 10.1111/nyas.14092. Epub 2019 Apr 22.

    PubMed 31008520
  • Ahmed F, Khan MR, Akhtaruzzaman M, Karim R, Marks GC, Banu CP, Nahar B, Williams G. Efficacy of twice-weekly multiple micronutrient supplementation for improving the hemoglobin and micronutrient status of anemic adolescent schoolgirls in Bangladesh. Am J Clin Nutr. 2005 Oct;82(4):829-35. doi: 10.1093/ajcn/82.4.829.

    PubMed 16210713
  • Gebreegziabher T, Stoecker BJ. Iron deficiency was not the major cause of anemia in rural women of reproductive age in Sidama zone, southern Ethiopia: A cross-sectional study. PLoS One. 2017 Sep 12;12(9):e0184742. doi: 10.1371/journal.pone.0184742. eCollection 2017.

    PubMed 28898272
  • Kassebaum NJ; GBD 2013 Anemia Collaborators. The Global Burden of Anemia. Hematol Oncol Clin North Am. 2016 Apr;30(2):247-308. doi: 10.1016/j.hoc.2015.11.002.

    PubMed 27040955
  • Multiple Micronutrient Supplement Technical Advisory Group (MMS-TAG); Micronutrient Forum (MNF). Expert consensus on an open-access United Nations International Multiple Micronutrient Antenatal Preparation-multiple micronutrient supplement product specification. Ann N Y Acad Sci. 2020 Jun;1470(1):3-13. doi: 10.1111/nyas.14322. Epub 2020 Mar 9.

    PubMed 32153024
  • Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.

    PubMed 27827838
  • Gomes F, Agustina R, Black RE, Christian P, Dewey KG, Kraemer K, Shankar AH, Smith ER, Thorne-Lyman A, Tumilowicz A, Bourassa MW. Multiple micronutrient supplements versus iron-folic acid supplements and maternal anemia outcomes: an iron dose analysis. Ann N Y Acad Sci. 2022 Jun;1512(1):114-125. doi: 10.1111/nyas.14756. Epub 2022 Feb 25.

    PubMed 35218047
  • Kuche D, Abebe Z, Tessema M, Girma M, Hussen A, Baye K, Stoecker BJ. The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT. Trials. 2024 Mar 6;25(1):170. doi: 10.1186/s13063-024-08024-w.

    PubMed 38448918

Questions about this trial

What is this clinical trial studying?

A study testing UNIMMAP-MMS and IFA in people with Anemia, run by Ethiopian Public Health Institute at 1 site in Ethiopia.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 7 Aug 2025. 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 Ethiopia. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in mean hemoglobin concentrations among women of reproductive age (time frame: Blood sample will be collected once at baseline and once at end-line in four months). The study lists 2 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 NCT05682261, which also lists 8 linked publications.

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 7 Aug 2025.

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