A Phase 1/2 interventional study of Lactoferrin and ferrous fumarate in Iron Deficiency Anemia of Pregnancy, sponsored by Assiut University. Status unknown. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by Assiut University · Phase 1/2, Interventional, and Treatment
Among 13 studies testing lactoferrin in Anemia, Iron-Deficiency — 1 open to participants now, 2 under way, none of them phase 3. Lactoferrin · Anemia, Iron-Deficiency.
Among the 13 studies testing lactoferrin in Anemia, Iron-Deficiency, this one is the 4th largest by planned enrollment, is one of 5 that started in 2018, is one of 2 in phase 1/2, and was the 3rd registered.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →1 of the 13 studies testing lactoferrin in Anemia, Iron-Deficiency is open now.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 16 Years to 45 Years · female · healthy volunteers too.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 5 started in 2018.
Median enrollment 100 across the 13 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
1 of 13 have an industry lead sponsor. The 10 most frequent:
Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
11 studies in Anemia, Iron-Deficiency by Assiut University: 5 open now, 5 under way, none of them phase 3. Of 2 finished, 0 (0%) have results posted.
Among the 11 studies in Anemia, Iron-Deficiency by Assiut University, this one is one of 2 that started in 2018, is the only one in phase 1/2, and was the 2nd registered.
Assiut University’s Anemia, Iron-Deficiency studies by the year they started, since 2016.
1 of the studies testing lactoferrin in Anemia, Iron-Deficiency that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07706582Beni-Suef UniversityManagement of Iron Deficiency Anemia in Hemodialysis Patients | 2026-12 |
Among the 13 studies testing lactoferrin in Anemia, Iron-Deficiency, from their registry updates:
Among Assiut University’s 11 in Anemia, Iron-Deficiency:
This study will conducted to evaluate and comparison between the effectiveness, safety and acceptability of lactoferrin alone, ferrous fumarate alone and combination of both for the treatment of mild to moderate IDA during pregnancy.
Anemia in pregnancy is a major public health problem, where it has been estimated that 41.8% of pregnant women worldwide are anemic .
Iron deficiency anemia (IDA) is the condition in which there is anemia due to a lack of iron. IDA develops when available iron is insufficient to support normal red cell production and is the most common type of anemia Anemia has a significant impact on the health of the fetus as well as that of the mother. It impairs the oxygen delivery through the placenta to the fetus and interferes with the normal intrauterine growth, leading to fetal loss and perinatal deaths. Anemia is associated with increased preterm labor (28.2%), preeclampsia (31.2%), and maternal sepsis.
The daily requirement of iron is around 1.5 mg in nonpregnant women. This requirement increases dramatically during pregnancy to reach 6-7 mg/day (total 1000 mg) with advanced gestational age. Pregnancy causes a twofold to threefold increase in the requirement for iron and a 10- to 20-fold increase in folate requirement. The increase in demand for iron is mainly due to fetal requirement, placenta, blood volume, tissue accretion, and the intra-partum potential for blood loss
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
women who take oral lactoferrin sachets 100 mg twice daily for one month.
Drug: Lactoferrin and ferrous fumarate
women who take oral ferrous fumarate tablet 30 mg elemental iron twice daily for one month.
Drug: Lactoferrin and ferrous fumarate
women who take lactoferrin sachets 100 mg and ferrous fumarate tablet 30 mg elemental iron once daily for one month.
Drug: Lactoferrin and ferrous fumarate
Drug pages: Lactoferrin · Ferrous fumarate
* Group 1:include 50 women will receive oral lactoferrin 100mg twice daily . * Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily . * Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily .
Also known as: pravotin sachets and vitayami tablets
Increase in blood hemoglobin.
mean difference in hemoglobin level between pre treatment and post treatment.
Time frame: one month
No study locations are listed for this record.
Start is estimated for Nov 2018; primary completion for Dec 2019, 13 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lactoferrin · Ferrous fumarate