Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

International Centre for Diarrhoeal Disease Research (icddr,b)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Vitamin A Deficiency

Treatments: Dietary Supplement: Vitamin A (<3-day postpartum); Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum); Dietary Supplement: Vitamin A (6 wk postpartum); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02043223

PR-13060

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.

Full description

The effect will be assessed by the milk and blood.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 32 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women >-18 years of age with low-risk obstetric

Exclusion criteria

• Pregnant women expecting a multiple birth
• Take vitamin A supplements during postpartum apart from study intervention
• Premature birth
• Newborn babies with birth defects and / or other serious diseases

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups

Early postpartum vitamin A suppl.

Experimental group

Description:

Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.

Treatment:

Dietary Supplement: Vitamin A (<3-day postpartum)

Late postpartum vitamin A suppl.

Experimental group

Description:

Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.

Treatment:

Dietary Supplement: Vitamin A (6 wk postpartum)

Early & late postpartum vitamin A suppl

Experimental group

Description:

200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum

Treatment:

Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum)

No postpartum vitamin A suppl.

Experimental group

Description:

Placebo supplementation, both at \<3-day and 6-wk postpartum.

Treatment:

Dietary Supplement: Placebo