Controlling Anemia During Pregnancy: Sprinkles Versus IFA Tablets

NCT06516081 | Completed

• 1 other identifier: 1000007390
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

'Very significant progress has been made but the job is less than half done' may summarise the efforts made to control vitamin A and iodine deficiency disorders. Unfortunately, in the case of iron deficiency, the most common nutritional deficiency in the world, the story is much worse. Among the population groups mostly affected by its associated anemia are pregnant women. In clinical trials, where the intake of daily doses of iron tablets has been ensured, it was shown that this intervention can prevent anemia. However, when this intervention has been implemented in non-research settings, it has had limited effect mainly due to associated side effects and lack of motivation bringing about low compliance. New effective strategies are thus needed to deliver iron and other micronutrients that would overcome the problem of low compliance. Micronutrient powders (MNPs) (Sprinkles®) are an innovative approach that delivers necessary micronutrients including iron and folic acid during pregnancy through home-based food fortification. The objectives of the current research proposal are to provide Sprinkles or iron and folic acid tablets to pregnant women in rural Bangladesh and compare outcomes including compliance and hematological status. If Sprinkles® are determined to be equivalent or better than the traditional iron and folic acid tablets, then the next step would be to determine the effectiveness of this new intervention.

Conditions

Anemia

Keywords

anemia; pregnancy; sprinkles; iron; folic acid

Outcome Measures

Primary Outcomes (3)

• Hemoglobin concentration (g/L)

  Hemoglobin concentration

  24 weeks of gestation

• Hemoglobin concentration (g/L)

  Hemoglobin concentration

  28 weeks of gestation

• Hemoglobin concentration (g/L)

  Hemoglobin concentration

  32 weeks of gestation

Secondary Outcomes (3)

• Adverse effects

  Weekly during weeks 2-7 following study recruitment.

• Adherence .

  Weekly during weeks 2-7 following study recruitment.

• Acceptability of the interventions

  Weekly during weeks 2-7 following study recruitment.

Study Arms (2)

Experimental arm

EXPERIMENTAL

Micronutrient powders (Sprinkles®). One sachet daily containing minerals and vitamins in powder form.

Dietary Supplement: Micronutrient powder (Sprinkles®)

Comparator arm

ACTIVE COMPARATOR

IFA tables daily

Dietary Supplement: Micronutrient powder (Sprinkles®)

Interventions

Micronutrient powder (Sprinkles®) DIETARY_SUPPLEMENT

Also known as: Iron folic acid tablets

Comparator arm; Experimental arm

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women, ages between 15-45 years, who have a gestational age between 14-20 weeks

You may not qualify if:

• Pregnant women with Hb \< 70 g/L (severely anemic according to WHO)
• Pregnant women already on iron supplementation prior to the study start
• Pregnant women with a known history of liver, heart or kidney disease, cancer or severe infections
• Pregnant women requiring significant medical care, above that normally received during pregnancy

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Heinz Endowments: collaborator

Study Sites (1)

Research and Evaluation Division, BRAC

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Stanley H Zlotkin, MD, PhD

  The Hospital for Sick Children, Toronto, Ontario Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Global Child Health

Model Details: Iron folic acid tablets versus micronutrient powders containing iron and folic acid (Sprinkles)

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: July 23, 2024
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

BA (1)