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Completed

NCT Number: NCT05682261

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

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 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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ethiopian Public Health Institute

Addis Ababa, 1242, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

UNIMMAP-MMS

Dietary 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.

IFA

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. 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

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

  2. Change in overall anemia among women of reproductive age

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

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

Secondary outcomes

  1. Change in mean ferritin concentration among women of reproductive age

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

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

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

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

    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

Sponsors and collaborators

Lead sponsor

Ethiopian Public Health Institute

Other Gov

Collaborators

  • Addis Ababa University
  • Oklahoma State University

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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