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| ID | Type | Description | Link |
|---|---|---|---|
| CNPq | Other Grant/Funding Number | 471872/08-3 |
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| Name | Class |
|---|---|
| Rio de Janeiro State University | OTHER |
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Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Inactive pill (microcrystalline cellulose and corn starch) taken daily | |
| Calcium plus vitamin D | Active Comparator | 600mg of calcium and 200 international units (IU) vitamin D taken daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium plus vitamin D | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in maternal bone mass changes postpartum between supplemented and placebo groups | 2, 5 and 12 months postpartum | |
| Differences in fetal growth and infant bone mass between supplemented and placebo groups | 2nd and 3rd trimester gestation and 2 mo postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups | 2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum | |
| Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flavia F Bezerra, DSc | Universidade do Estado do Rio de Janeiro, Brazil | Principal Investigator |
| Carmen M Donangelo, PhD | Universidade Federal do Rio de Janeiro, Brazil | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. | |
| 37166151 | Derived | Rached V, Diogenes MEL, Donangelo CM, Bezerra FF. Calcium plus vitamin D supplementation during pregnancy reduces postpartum fat mass in adolescents: A randomized trial. Am J Hum Biol. 2023 Sep;35(9):e23911. doi: 10.1002/ajhb.23911. Epub 2023 May 11. |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| 2 months postpartum |
| Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms | 2, 5 and 12 months postpartum |
| Differences in infant body composition between supplemented and placebo groups | 2 months postpartum |
| Differences in changes of maternal body composition postpartum between supplemented and placebo groups | 2, 5 and 12 months postpartum |
| 26019245 | Derived | Diogenes ME, Bezerra FF, Rezende EP, Donangelo CM. Calcium Plus Vitamin D Supplementation During the Third Trimester of Pregnancy in Adolescents Accustomed to Low Calcium Diets Does Not Affect Infant Bone Mass at Early Lactation in a Randomized Controlled Trial. J Nutr. 2015 Jul;145(7):1515-23. doi: 10.3945/jn.114.208140. Epub 2015 May 27. |
| 23719547 | Derived | Diogenes ME, Bezerra FF, Rezende EP, Taveira MF, Pinhal I, Donangelo CM. Effect of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers: a randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Jul;98(1):82-91. doi: 10.3945/ajcn.112.056275. Epub 2013 May 29. |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |