Potential Harms of Untargeted Iron Supplementation in Cambodia Where Iron Deficiency is Not the Cause of Anemia

Summary

In 2016, the World Health Organization (WHO) set a global policy recommending daily oral iron supplementation (60 mg iron) for 12 weeks for all women living in countries where anemia prevalence is \>40%, such as in Cambodia. However, recent studies have shown the prevalence of iron deficiency to be low in Cambodian women and that supplementation would likely only benefit \~10% of women.

Iron supplementation may be harmful in women with genetic blood disorders (e.g. thalassemia), which are common in Cambodia, as these individuals are already at an increased risk of iron overload. The risks are made greater by the fact that iron absorption from most common form of supplementation, ferrous sulfate, is low. Typically less than 20% is absorbed in the gut; the remaining 80% passes unabsorbed into the colon where it can increase the risk of pathogen growth and gut inflammation. Alternatively, ferrous bisglycinate is a newer supplemental form of iron. This amino acid chelate has 2-4x higher bioavailability than ferrous sulfate and is associated with fewer GI side-effects.

In view of WHO policy and risks of supplementation, there is a need to determine the potential for harm, and if novel forms of iron supplements are safer.

Conditions

• Anemia, Iron Deficiency
• Anemia
• Intestinal Inflammation
• Inflammation
• Intestine; Complaints

Interventions

DIETARY_SUPPLEMENT

Ferrous sulfate

60 mg elemental iron as ferrous sulfate

DIETARY_SUPPLEMENT

Ferrous Bisglycinate

18 mg elemental iron as ferrous bisglycinate

DIETARY_SUPPLEMENT

Placebo of microcrystalline cellulose

placebo

Sponsors & Collaborators

• Helen Keller International

  collaborator OTHER

• NCHADS - Ministry of Health of Cambodia

  collaborator OTHER

• BC Children's Hospital Research Institute

  collaborator OTHER

• The National Institute of Public Health Laboratory, Phnom Penh

  collaborator UNKNOWN

• University of British Columbia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-12-10

Primary Completion

2020-05-30

Completion

2023-12-01

Countries

• Cambodia

Study Locations