Lactation Bone LossNCT01732328
Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health
A study testing Calcium plus vitamin D in people with Lactation Bone Loss and Infant Bone Growth, run by Universidade Federal do Rio de Janeiro.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Bone Loss, Infant Bone Growth
- What is being tested?
- Calcium plus vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-19 y old
- between 23 and 29 wk of gestation
- primiparous
- carrying single fetus
- intending to exclusively or predominantly breastfeed
Who cannot join
- chronic health problems
- smokers
- users of nutritional supplements, except iron supplements provided during standard prenatal care
About this study
Official title: Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
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.
- Conditions
- Lactation Bone Loss, Infant Bone Growth
- Being tested
- Calcium plus vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium plus vitamin DDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Calcium plus vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in maternal bone mass changes postpartum between supplemented and placebo groups
Measured: 2, 5 and 12 months postpartum
Differences in fetal growth and infant bone mass between supplemented and placebo groups
Measured: 2nd and 3rd trimester gestation and 2 mo postpartum
Secondary outcomes (5)
Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups
Measured: 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
Measured: 2 months postpartum
Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms
Measured: 2, 5 and 12 months postpartum
Differences in infant body composition between supplemented and placebo groups
Measured: 2 months postpartum
Differences in changes of maternal body composition postpartum between supplemented and placebo groups
Measured: 2, 5 and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lactation Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State University
- Responsible party
- Principal investigator, Flavia Fioruci Bezerra, Rio de Janeiro State University
- Investigators
- Flavia F Bezerra, DSc, Principal investigator, Universidade do Estado do Rio de Janeiro, BrazilCarmen M Donangelo, PhD, Study director, Universidade Federal do Rio de Janeiro, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732328
- Sponsor's protocol ID
- CAAE 0002.0361.000-09
- Other IDs
- CNPq
- Status last verified
- Nov 2012
- First submitted
- 19 Nov 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39077939Rached 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.
PubMed 37166151Diogenes 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.
PubMed 26019245Diogenes 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.
PubMed 23719547
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
- ClinicalTrials.gov ID
- NCT01732328
- Acronym / sponsor ID
- CAAE 0002.0361.000-09
- Conditions
- Lactation Bone Loss, Infant Bone Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State University
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | –Inactive pill (microcrystalline cellulose and corn starch) taken daily |
| Calcium plus vitamin D | Active comparator | Dietary Supplement: Calcium plus vitamin D600mg of calcium and 200 international units (IU) vitamin D taken daily |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 13-19 y old
- between 23 and 29 wk of gestation
- primiparous
- carrying single fetus
- intending to exclusively or predominantly breastfeed
Key exclusion criteria (3 listed)
- chronic health problems
- smokers
- users of nutritional supplements, except iron supplements provided during standard prenatal care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium plus vitamin D | Dietary supplement | Calcium plus vitamin D |
Primary outcome
Differences in maternal bone mass changes postpartum between supplemented and placebo groups
Time frame: 2, 5 and 12 months postpartum
Differences in fetal growth and infant bone mass between supplemented and placebo groups
Time frame: 2nd and 3rd trimester gestation and 2 mo postpartum
5 secondary outcomes
Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups
Time frame: 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
Time frame: 2 months postpartum
Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms
Time frame: 2, 5 and 12 months postpartum
Differences in infant body composition between supplemented and placebo groups
Time frame: 2 months postpartum
Differences in changes of maternal body composition postpartum between supplemented and placebo groups
Time frame: 2, 5 and 12 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Derived from this study: PubMed 39077939Palacios 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.
- Derived from this study: PubMed 37166151Rached 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.
- Derived from this study: PubMed 26019245Diogenes 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.
- Derived from this study: PubMed 23719547Diogenes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia F Bezerra, DSc principal investigator
Universidade do Estado do Rio de Janeiro, Brazil
Carmen M Donangelo, PhD study director
Universidade Federal do Rio de Janeiro, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Calcium plus vitamin D in people with Lactation Bone Loss and Infant Bone Growth, run by Universidade Federal do Rio de Janeiro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in maternal bone mass changes postpartum between supplemented and placebo groups (time frame: 2, 5 and 12 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732328, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.