Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health

NCT02221752 | Completed DMC

• 1 other identifier: Vifor/PFH supplement trial
• Study Type: interventional
• Target: 2,367
• Locations: 1 country
• Sites: 1

Brief Summary

According to a national study in 2002, the prevalence of ID, IDA, and ID+IDA among pregnant women in China was 42.6%, 9.1%, and 61.7% respectively. A similar study in Hebei province at the same time showed that the prevalence of IDA among pregnant and lactating mothers was 46.39% and 47.21% respectively. There was a significant difference between urban and rural areas. Women living in rural areas had higher chances of having IDA (p\<0.01). WHO and UNICEF recommend taking iron, folic acid and multiple micronutrients during pregnancy. However, we don't know much about their influence on maternal and infant health and their clinical effectiveness. Health Department of China recommends taking 400ug folic acid before pregnancy and during early pregnancy. But for various reasons, not all expecting mothers take this advice. Besides, we don't have a national level technical standard of how to take nutrition supplements during pregnancy. Therefore, it's crucial for us to study if iron/folic acid or folic acid only can prevent perinatal complications, as well as their influences on infant and toddler health. The purpose of this study is to test whether taking iron/folic acid and folic acid only from early pregnancy until delivery will lower the chances of pregnancy complications, and to see how supplements affect gestation results. As well, it will evaluate a) whether taking iron supplement during pregnancy can prevent IDA during pregnancy; b) whether taking iron supplement can increase mother and fetus iron storage; and c) how mother's iron level affects newborn's iron level. We hope to understand nutrition conditions during pregnancy and investigate the relations between pregnancy diet and complications during pregnancy, weight gain during pregnancy, and newborn birth weight. We will evaluate the influence of taking iron and folic acid during pregnancy on the health of infants and toddlers.

Conditions

Iron Deficiency; Iron Deficiency Anemia

Keywords

iron deficiency; iron deficiency anemia; infant; pregnancy

Outcome Measures

Primary Outcomes (2)

• Maternal iron status at follow-up prenatal visit

  26-30 weeks

• Maternal iron status at follow-up prenatal visit

  36-40 weeks

Secondary Outcomes (3)

• Cord-blood iron status

  delivery

• Infant gestational age

  delivery

• Infant birth weight

  delivery

Study Arms (2)

Folic acid

EXPERIMENTAL

Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.

Dietary Supplement: Folic acid

Ferrous Sulfate + folic acid

EXPERIMENTAL

Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate \[60 mg elemental iron\]) and the other with 0.40 mg folic acid from enrollment to delivery.

Dietary Supplement: Ferrous Sulfate + folic acid

Interventions

Ferrous Sulfate + folic acid DIETARY_SUPPLEMENT

Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate \[60 mg elemental iron\]) and the other with 0.40 mg folic acid from enrollment to delivery.

Ferrous Sulfate + folic acid

Folic acid DIETARY_SUPPLEMENT

Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.

Folic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation -

You may not qualify if:

• \< 18 years of age
• did not live in the county
• did not anticipate delivery at participating hospital
• were not mentally competent
• had a chronic health problem or hemoglobin \< 100 g/L at the initial visit
• were taking iron at the time.

Sponsors & Collaborators

• Zhao gengli: lead
• Vifor Pharma: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (2)

• Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.

  PMID: 39145520 DERIVED

• Zhao G, Xu G, Zhou M, Jiang Y, Richards B, Clark KM, Kaciroti N, Georgieff MK, Zhang Z, Tardif T, Li M, Lozoff B. Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates. J Nutr. 2015 Aug;145(8):1916-23. doi: 10.3945/jn.114.208678. Epub 2015 Jun 10.

  PMID: 26063068 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Interventions

ferrous sulfate; Folic Acid

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhao Gengli, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: June 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

CN (1)