NCT03542825

Oral Lactoferrin Versus Iron Supplementation During Pregnancy

Completed Phase 4 Last updated 28 December 2018

What this trial tests

Phase 4 trial testing Lactoferrin in Iron-deficiency in 300 participants. Completed in 1 October 2018.

Timeline

1 January 2018

Primary endpoint
1 September 2018

1 October 2018

Quick facts

Lead sponsor	South Valley University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	300
Start date	1 January 2018
Primary completion	1 September 2018
Estimated completion	1 October 2018
Sites	1 location across Egypt

Drugs / interventions tested

• Lactoferrin — full drug profile →
• Iron Supplement — full drug profile →
• Chelates, Iron — full drug profile →

Conditions studied

• Iron-deficiency — all drugs for Iron-deficiency →

Sponsor

South Valley University

Who can join

Adults 20 to 40, female only, with Iron-deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. The oral route is preferred to the parenteral route to replace iron stores \[Sharma JB; et al., 2004\]. Inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ So¨lvell L; et al., 1970\].

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.