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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05682261
• Other study ID #: EPHI_IRB_410_2021_2
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: October 2023

Study information

• Verified date: September 2023
• Source: Ethiopian Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 265
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Dietary Supplement:
• UNIMMAP-MMS
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
The study participants in this arm will receive iron-folic acid supplements with 30 mg of iron and 400 µg of folic acid.

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

Locations

Country	Name	City	State
Ethiopia	Ethiopian Public Health Institute	Addis Ababa

Sponsors (3)

Lead Sponsor	Collaborator
Ethiopian Public Health Institute	Addis Ababa University, Oklahoma State University

Country where clinical trial is conducted

Ethiopia, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. Erratum In: PLoS One. 2017 Dec 7;12 (12 ):e0189553. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Blood sample will be collected once at baseline and once at end-line in four months
Primary	Change in overall anemia among women of reproductive age	Anemia diagnosed when hemoglobin concentration test result is less than 12 g/dl	Blood sample will be collected once at baseline and once at end-line in four months
Secondary	Change in mean ferritin concentration among women of reproductive age	Ferritin concentration is measured from serum ferritin in µg/L.	The serum samples will be collected once at the baseline and once at the end-line in four months
Secondary	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	Blood sample will be collected once at baseline and once at end-line in four months