Multiple Micronutrient Supplementation (MMS) vs IFA Acceptability Crossover Trial

Sponsor
George Washington University
Study ID
NCT06069856
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Iron Folic Acid Tablets with 60 mg of iron — DIETARY_SUPPLEMENT
    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
  • Multiple Micronutrient Supplements with 60 mg of elemental iron — DIETARY_SUPPLEMENT
    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.

Study Details

This is an open-label individually randomized mixed methods cross-over trial to assess acceptability, preference, and side effects of IFA formulations with 60 mg of iron to MMS formulations with 60 mg of iron.

Key Dates

First listed
Oct 6, 2023
Start date
Jun 1, 2027
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: MMS with 60 mg of iron first, then IFA with 60 mg of iron
    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
  • Experimental: IFA with 60 mg of iron first, then MMS with 60 mg of iron
    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

Primary Outcome Measure

Acceptability of formulation [ Time Frame: At two months of taking each regimen ]

Central Contacts

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