Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania ( MMS-MAP ) - MMS vs IFA Trial

Study Overview
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Brief Summary
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This is a mixed methods cross-over study to compare acceptability of IFA with 60 mg of iron to MMS with 60 mg of iron. This cross-over study will help contribute evidence to the remaining question about acceptability, preference adherence, and side effects between IFA and MMS (with the same amount of iron). By holding the amount of iron constant, the study can help answer the question about whether the addition of micronutrients affects adherence or acceptability.

Official Title
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Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia- MMS Versus IFA Crossover Trial

Conditions
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Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron
* Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Attending first ANC visit at the study clinic Pregnant women ≤ 15 weeks of gestation Aged ≥ 18 years Intending to stay in the study area for the duration of study Provides informed consent Exclusion Criteria: Severe anemia (defined as Hb <8.5 g/dL per Tanzania standard of care) Sickle cell disease (homozygous) as tested by HemoTypeSC Concurrent participation in other nutritional supplementation trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMS with 60 mg of iron first, then IFA with 60 mg of iron<br>Women will receive the first regimen (MMS with 60 mg of iron) for 2 months and then crossover on to the second regimen (IFA with 60 mg of iron) for 2 months | Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron<br>* IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.<br>|
| Experimental: IFA with 60 mg of iron first, then MMS with 60 mg of iron<br>Women will receive the first regimen (IFA with 60 mg of iron) for 2 months and then crossover on to the second regimen (MMS with 60 mg of iron) for 2 months | Dietary Supplement: Iron Folic Acid Tablets with 60 mg of iron<br>* IFA with 60 mg iron is an intervention group. IFA with 60 mg of iron will be taken orally once daily from the time of randomization<br>Dietary Supplement: Multiple Micronutrient Supplements with 60 mg of elemental iron<br>* MMS with 60 mg iron is an intervention group. MMS with 60 mg of iron plus standard UNIMMAP formulation for other 14 micronutrients will be taken orally once daily from the time of randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of MMS formulation | To assess acceptability of MMS formulation with 60 mg of iron using Likert scales | Month 1 | 
| Preference of MMS formulation | To assess preference of MMS formulation with 60 mg of iron using questionnaires | Month 1 | 
| Side Effects of MMS formulation | To assess perceived side effects of MMS formulation with 60 mg of iron through questionnaires | Month 1 | 
| Acceptability of MMS formulation | To assess acceptability of MMS formulation with 60 mg of iron using Likert scales | Month 2 | 
| Preference of MMS formulation | To assess preference of MMS formulation with 60 mg of iron using questionnaires | Month 2 | 
| Side Effects of MMS formulation | To assess perceived side effects of MMS formulation with 60 mg of iron using questionnaires | Month 2 | 
| Acceptability of MMS formulation | To assess acceptability of MMS formulation with 60 mg of iron using Likert scales | Month 3 | 
| Preference of MMS formulation | To assess preference of MMS formulation with 60 mg of iron using questionnaires | Month 3 | 
| Side Effects of MMS formulation | To assess perceived side effects of MMS formulation with 60 mg of iron using questionnaires | Month 3 | 
| Acceptability of IFA formulation | To assess acceptability of IFA containing 60 mg of iron using Likert scale | Month 1 | 
| Preference of IFA formulation | To assess preference of IFA containing 60 mg of iron using questionnaires | Month 1 | 
| Side Effects of IFA formulation | To assess perceived side effects of IFA containing 60 mg of iron using questionnaires | Month 1 | 
| Acceptability of IFA formulation | To assess acceptability of IFA containing 60 mg of iron using Likert scale | Month 2 | 
| Preference of IFA formulation | To assess preference of IFA containing 60 mg of iron using questionnaires | Month 2 | 
| Side Effects of IFA formulation | To assess perceived side effects of IFA containing 60 mg of iron using questionnaires | Month 2 | 
| Acceptability of IFA formulation | To assess acceptability of IFA containing 60 mg of iron using Likert scales | Month 3 | 
| Preference of IFA formulation | To assess preference of IFA containing 60 mg of iron using questionnaires | Month 3 | 
| Side Effects of IFA formulation | To assess perceived side effects of IFA containing 60 mg of iron using questionnaires | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Micronutrient Supplementation, Iron, IFA, Tanzania, Pregnancy