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| Name | Class |
|---|---|
| Peter Bergman, MD, PhD | UNKNOWN |
| Karolinska University Hospital | OTHER |
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The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.
The effect will be assessed by the milk and blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early postpartum vitamin A suppl. | Experimental | Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. |
|
| Late postpartum vitamin A suppl. | Experimental | Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. |
|
| Early & late postpartum vitamin A suppl | Experimental | 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum |
|
| No postpartum vitamin A suppl. | Experimental | Placebo supplementation, both at <3-day and 6-wk postpartum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A (<3-day postpartum) | Dietary Supplement | Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast milk immune regulators | immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points-
| Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Infant T helper cell immune responses | Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points-
| Four months |
| Measure | Description | Time Frame |
|---|---|---|
| Infant vitamin A status | Infant plasma vitamin A status at 7 wk and 15 wk of age | Four months |
| Infant growth | Infant Weight-for-Age z-score (WAZ) at 7 wk and 15 wk of age |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaikh M Ahmad, Ph.D | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | Dhaka | 1212 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25872802 | Derived | Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9. |
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| ID | Term |
|---|---|
| D014802 | Vitamin A Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| D049590 | Postpartum Period |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Vitamin A (6 wk postpartum) | Dietary Supplement | Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum. |
|
| Vitamin A (<3-day and 6 wk postpartum) | Dietary Supplement | 200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum |
|
| Placebo | Dietary Supplement | Placebo supplementation, both at <3-day and 6-wk postpartum. |
|
| Infant innate immune responses | Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points-
| Four months |
| Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses | Hepatitis B and Tetanus Toxoid specific plasma cell IgG responses at 15 wk of age (1wk after three doses of pentavalent vaccination) And Hepatitis B and Tetanus Toxoid specific IgG in plasma and Polio (3 serotypes) specific secretory IgA (sIgA) in stool at two time points-
| Four months |
| Relative abundance of infant gut microbial community and gut inflammatory markers | Next generation sequencing (NGS) of bacterial 16s rDNA (+qPCR) in extracted stool samples and assessment of infant gut inflammatory markers e.g. human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points-
| Four months |
| Four months |
| Infant morbidity | Infant morbidity status up to four months of age | Four months |
| Mother vitamin A status | Plasma Retinol Binding Protein (RBP) and breast milk vitamin A level at two time points-
| Four months |
| D009750 |
| Nutritional and Metabolic Diseases |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |